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
- G59064 FDA UDI
- Description
- Fortify TRG Tissue Repair Graft FDA UDI
Identifiers
- Catalog Number
- FTRG-4X7-S FDA UDI
- Primary DI / UDI-DI
- 00827002590649 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
A comprehensive medical device review, providing detailed information on the Fortify TRG Tissue Repair Graft. Learn about its features, compliance, and FAQs.
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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 |
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Manufacturer
- Manufacturer
- Cook Biotech Incorporated
Sources (1)
- FDA UDI 86f6e6ff-8a21-4c04-bff5-4f36111df541 37 fields · synced Jun 29, 2026