SOLICITATION NOTICE
65 -- Surgical_Mesh_Synthetic - RFI Vendor Response Package Worksheet
- Notice Date
- 10/23/2017
- Notice Type
- Presolicitation
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Defense Logistics Agency, DLA Acquisition Locations, DLA Troop Support - Medical, 700 Robbins Avenue, Philadelphia, Pennsylvania, 19111-5096, United States
- ZIP Code
- 19111-5096
- Solicitation Number
- RFI_Surgical_Mesh_Synthetic
- Point of Contact
- Mr. Ricardo U. Orias, Phone: 619-532-8537, Ms. Gabrielle Burns, Phone: 619-532-7554
- E-Mail Address
-
ricardo.u.orias.ctr@mail.mil, gabrielle.m.burns2.ctr@mail.mil
(ricardo.u.orias.ctr@mail.mil, gabrielle.m.burns2.ctr@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Complete answers and all supporting documentation must be provided with the vendor’s submittal by the response date stated in the RFI notification. Vendor must provide responses to the Sources Sought notification via the RFI Vendor Response Package Worksheet. REQUEST FOR INFORMATION (RFI) Surgical Mesh, Synthetic 1. Introduction 1.1 General. The purpose of this request is to obtain information from industry to support the government's intent to establish a Qualified Supplier List (QSL) for the Standardization of Surgical Mesh, Synthetic. This Request for Information (RFI) is an invitation to submit to Department of Defense (DoD) and DHA MEDLOG the following: Technical information and all related supporting documentation for Surgical Mesh, Synthetic. This request is a market research effort undertaken by the Government which will be used for information gathering purposes. The information received may be used for Acquisition Planning purposes and will help define future requirements for the subject item. This is not a request for quote or proposal. 1.2 RFI Submission Package. Vendors must provide responses to this RFI via the RFI Vendor Response Package Worksheet. Complete answers and all supporting documentation must be provided with the vendor's submittal. 2. Scope The Surgical Mesh, Synthetic product line includes but is not limited to: Surgical Mesh, Synthetic for adult and pediatric application; single use; not made with natural rubber latex; can be absorbable, non-absorbable or a combination of absorbable and non-absorbable materials; in various sizes, thickness, and shapes. 3. Characteristics/Specifications Feedback Requested: Respondents are requested to provide information concerning their Surgical Mesh, Synthetic regarding the following questions: 3.1 Are your Surgical Mesh, Synthetic products manufactured in a TAA compliant country? Please identify the country(ies) of origin. 3.2 Are your Surgical Mesh, Synthetic products FDA approved? Please provide documentation to support approval. Materials 3.3 Please list the material composition of all of your Surgical Mesh, Synthetic product lines. 3.4 Please indicate which Surgical Mesh, Synthetic products come with a coated mesh and specify the coating material used. Absorbability 3.5 Please list your Surgical Mesh, Synthetic products considered non-absorbable by industry standards. Please provide manufacturer product/part numbers for these products. 3.6 Please list Surgical Mesh, Synthetic products considered partially absorbable by industry standards. Please provide manufacturer product/part numbers for these products. Fixation 3.7 Can your Surgical Mesh, Synthetic products be used with universal fixation devices? 3.8 Please list your Surgical Mesh, Synthetic products that are considered self-fixating and provide manufacturer product/part numbers for these products. Inguinal Plug Mesh 3.9 Please list all of the available dimensions of your Inguinal Plug Mesh products and provide manufacturer product/part numbers for these products. 3.10 Please list your Inguinal Plug Mesh products made from lightweight mesh and provide manufacturer product/part numbers for these products. 3.11 Please list your Inguinal Plug Mesh products that come with straps and provide manufacturer product/part numbers for these products. 3.12 Please list your Inguinal Plug Mesh products that come with a small piece of mesh to lay over it and provide manufacturer product/part numbers for these products. 3.13 Please list your Inguinal Plug Mesh products that come with a coating and provide manufacturer product/part numbers for these products. Inguinal Mesh 3.14 Please list your Inguinal Sheet Mesh, Synthetic products that are specific to right or left side and provide manufacturer product/part numbers for these products. 3.15 Please list your bilateral Inguinal Sheet Mesh, Synthetic products and provide manufacturer product/part numbers for these products. 3.16 Please list dimensions of your Inguinal Sheet Mesh, Synthetic products and provide manufacturer product/part numbers for these products. 3.17 Please list your Inguinal Mesh, Synthetic products made with lightweight mesh and provide manufacturer product/part numbers for these products. 3.18 Please list your Inguinal Mesh, Synthetic products that are considered macro porous or large pore by industry standards and provide manufacturer product/part numbers for these products. 3.19 Please list all of the shapes available for your Inguinal Mesh, Synthetic products and provide manufacturer product/part numbers for these products. 3.20 Please list your Inguinal Mesh, Synthetic products that come with coating and provide manufacturer product/part numbers for these products. 3.21 Please list dimensions of your Inguinal Patch Mesh products and provide manufacturer product/part numbers for these products. 3.22 Please list your Inguinal Patch Mesh products that come with a keyhole cut and provide manufacturer product/part numbers for these products. Ventral Mesh 3.23 Please list and provide manufacturer product/part numbers for your bilateral Ventral Sheet Mesh, Synthetic products. 3.24 Please list dimensions of your Ventral Sheet Mesh, Synthetic products and provide manufacturer product/part numbers for these products. 3.25 Please list all of your Ventral Mesh, Synthetic products made with lightweight mesh and provide manufacturer product/part numbers for these products. 3.26 Please list your Ventral Mesh, Synthetic products that are considered macro porous or large pore by industry standards and provide manufacturer product/part numbers for these products. 3.27 Please list all of the different shapes available for your Ventral Mesh, Synthetic products and provide manufacturer product/part numbers for these products. 3.28 Please list your Ventral Mesh, Synthetic products that have a coating and provide manufacturer product/part numbers for these products. 3.29 Please list all dimensions for your Ventral Patch Mesh, Synthetic products and provide manufacturer product/part numbers for these products. 3.30 Please list your Ventral Patch Mesh, Synthetic products that come with a keyhole cut and provide manufacturer product/part numbers for these products. Inguinal/Ventral Mesh 3.31 Please list and provide your manufacturer product/part numbers for bilateral Inguinal/Ventral Sheet Mesh, Synthetic products. 3.32 Please list dimensions of your Inguinal/Ventral Sheet Mesh, Synthetic products and provide manufacturer product/part numbers for these products. 3.33 Please list your Inguinal/Ventral Sheet Mesh, Synthetic products primarily made from polyglycolic acid and provide manufacturer product/part numbers for these products. 3.34 Please list your Inguinal/Ventral Mesh, Synthetic products made with lightweight mesh and provide manufacturer product/part numbers for these products. 3.35 Please list your Inguinal/Ventral Mesh, Synthetic products considered macro porous or large pore by industry standards and provide manufacturer product/part numbers for these products. 3.36 Please list all of the different shapes available for your Inguinal/Ventral Mesh, Synthetic products and provide manufacturer product/part numbers for these products. 3.37 Please list your Inguinal/Ventral Mesh, Synthetic products that have a coating and provide manufacturer product/part numbers for these products. 3.38 Please list dimensions of your Inguinal/Ventral Patch Mesh, Synthetic products and provide manufacturer product/part numbers for these products. 3.39 Please list your Inguinal/Ventral Patch Mesh, Synthetic products that come with a keyhole cut and provide manufacturer product/part numbers for these products. Transvaginal Mid-Urethral Sling Mesh 3.40 Please list your bilateral Transvaginal Mid-Urethral Sling Mesh, Synthetic products and provide manufacturer product/part numbers for these products. 3.41 Please list dimensions of your Transvaginal Mid-Urethral Sling Mesh, Synthetic products and provide manufacturer product/part numbers for these products. 3.42 Please list your Transvaginal Mid-Urethral Sling Mesh, Synthetic products made with lightweight mesh and provide manufacturer product/part numbers for these products. 3.43 Please list your Transvaginal Mid-Urethral Sling Mesh, Synthetic products that are considered macro porous or large pore by industry standards and provide manufacturer product/part numbers for these products. 3.44 Please list your Transvaginal Mid-Urethral Sling Mesh, Synthetic products that come with a coating and provide manufacturer product/part numbers for these products. 3.45 Please list your Transvaginal Mid-Urethral Sling Mesh, Synthetic products that have a transobturator and provide manufacturer product/part numbers for these products. 4. Additional Information Requested Please complete the attached response spreadsheet with indicated information about your Surgical Mesh, Synthetic products. 4.1 Have your Surgical Mesh, Synthetic products been subject to any recall(s)? If so, what corrective actions and/or product modifications have been made in response to the recall(s)? 4.2 Would your company be interested in responding to a future acquisition for the Surgical Mesh, Synthetic project outlined in this RFI? 4.3 Is there anything in the stated characteristics that you would not be able to support? If so, please provide an explanation. 4.4 Are we asking for characteristics of products that are not recommended? Why? 4.5 Please provide any additional information including relative topics outside of the specific information requested which you consider relevant. 4.6 Please list all standards your Surgical Mesh, Synthetic products currently meet. 4.7 Any information provided in response to this RFI will be considered and treated as unrestricted information which can be used by the Government in any future planning or acquisitions. DLA Troop Support does not anticipate awarding or modifying a contract in response to this RFI. All information comments and suggestions determined to be beneficial to DLA Troop Support may be incorporated into future acquisition documents or contracts, without identifying the source or obtaining prior approval from the source. 5. Liability The Government shall not be responsible or liable for any costs incurred by any party in the preparation and submission of any response to this RFI. 6. RFI Responses 6.1 Vendor responses to this RFI must be received by this office no later than 1700 (PST) on 06 November 2017. 6.2 Supporting documentation is required to be provided by the offeror as attachments to this RFI. The RFI Vendor Response Worksheet must be completely filled out and submitted timely along with all supporting material such as but not limited to product catalogs, sale sheets, Training Literature, FDA approval documentation and information, etc. 6.3 Responses and/or questions to this RFI must be submitted via e-mail to the points of contact listed below (section 7). E-mail responses should be no larger than 5 megabytes (MB) in size. If larger attachments are required, additional methods to submit responses include: 6.3.1 Sending documents separately due to size restrictions, as long as each e-mail indicates how many total e-mails are being sent. 6.3.2 The following website can be used for file transfer: AMRDEC safe site file transfer: https://safe.amrdec.army.mil/safe/ 6.4 The vendors' responses shall include all detailed information requested in the RFI Vendor Response Worksheet and shall also include: (1) Company name and address; (2) Company POC (Name and Phone Number, Fax Number, and E-mail address); (3) Company website information; and (4) the Company's Commercial and Government Entity (CAGE) Code. Each RFI response will receive a confirmation e-mail. 6.5 Vendor questions regarding this RFI are due no later than 1700 (PST) on 02 November 2017. 7. Points of Contact (POC) Mr. Ric Orias, MMESO West Team Lead, ricardo.u.orias.ctr@mail.mil, 619-532-8537, and Ms. Gabrielle Burns, MMESO West Clinical Analyst, Gabrielle.m.burns2.ctr@mail.mil, 619-532-7554.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DLA/J3/DSCP-M/RFI_Surgical_Mesh_Synthetic/listing.html)
- Place of Performance
- Address: Medical Materiel Enterprise Standardization Office (MMESO) West, 34960 Bob Wilson Dr., San Diego, California, 92134, United States
- Zip Code: 92134
- Zip Code: 92134
- Record
- SN04720284-W 20171025/171023230855-e558251aa3cf900d02642ad594595c80 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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