Identity
- Trade Name
- Fortify FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- Fortify TRG Tissue Repair Graft FDA UDI
- Model / Reference
- G58331 FDA UDI
- Description
- Fortify TRG Tissue Repair Graft FDA UDI
Identifiers
- Catalog Number
- C-SLH-4S-7X20-11 FDA UDI
- Primary DI / UDI-DI
- 10827002583310 FDA UDI
- FDA Product Code
- FTM FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fortify by Cook Biotech Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial.
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Cleared under the same submission
K191696 also covers:
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
K980431 also covers:
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
- Fortify — COOK BIOTECH INCORPORATED
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Biotech Incorporated
Sources (1)
- FDA UDI 8a0b8350-9398-4b36-8db7-a4ce39a2839d 37 fields · synced Jun 1, 2026