Identity
- Trade Name
- Biodesign FDA UDI
- Generic Name
- Fistula-repair biomatrix implant FDA UDI
- Device Name
- Biodesign Fistula Plug FDA UDI
- Model / Reference
- G54202 FDA UDI
- Description
- Biodesign Fistula Plug FDA UDI
Identifiers
- Catalog Number
- C-FP-0.7 FDA UDI
- Primary DI / UDI-DI
- 00827002542020 FDA UDI
- FDA Product Code
- FTM FDA UDI
- GMDN Term
- Fistula-repair biomatrix implant 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: Fistula-repair biomatrix implant
Biodesign by Cook Biotech Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fistula-repair biomatrix implant.
- Biodesign — COOK BIOTECH INCORPORATED · Class II
- Biodesign — COOK BIOTECH INCORPORATED · Class II
- Biodesign — COOK BIOTECH INCORPORATED · Class II
Cleared under the same submission
K062729 also covers:
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 4d12dcec-f696-41f6-af77-327b9707d7f9 37 fields · synced May 30, 2026