Identity
- Trade Name
- DynaMatrix Plus FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- DynaMatrix Plus Extracellular Membrane FDA UDI
- Model / Reference
- G56899 FDA UDI
- Description
- DynaMatrix Plus Extracellular Membrane FDA UDI
Identifiers
- Catalog Number
- 10.501.1030 FDA UDI
- Primary DI / UDI-DI
- 00827002568990 FDA UDI
- FDA Product Code
- NPL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 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
DynaMatrix Plus 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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- Strattice Reconstructive Tissue Matrix — LIFECELL CORP · Class II
- Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Medium — Smith & Nephew, Inc. · Class II
- Permacol — SOFRADIM PRODUCTION · Class II
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Cleared under the same submission
K082058 also covers:
- DynaMatrix — COOK BIOTECH INCORPORATED
- DynaMatrix — COOK BIOTECH INCORPORATED
- DynaMatrix — COOK BIOTECH INCORPORATED
- DynaMatrix — COOK BIOTECH INCORPORATED
- DynaMatrix — COOK BIOTECH INCORPORATED
- DynaMatrix — COOK BIOTECH INCORPORATED
- DynaMatrix Plus — COOK BIOTECH INCORPORATED
- DynaMatrix Plus — COOK BIOTECH INCORPORATED
- DynaMatrix Plus — COOK BIOTECH INCORPORATED
- DynaMatrix Plus — COOK BIOTECH INCORPORATED
- DynaMatrix Plus — COOK BIOTECH INCORPORATED
K161762 also covers:
- DynaMatrix — COOK BIOTECH INCORPORATED
- DynaMatrix — COOK BIOTECH INCORPORATED
- DynaMatrix — COOK BIOTECH INCORPORATED
- DynaMatrix — COOK BIOTECH INCORPORATED
- DynaMatrix — COOK BIOTECH INCORPORATED
- DynaMatrix — COOK BIOTECH INCORPORATED
- DynaMatrix Plus — COOK BIOTECH INCORPORATED
- DynaMatrix Plus — COOK BIOTECH INCORPORATED
- DynaMatrix Plus — COOK BIOTECH INCORPORATED
- DynaMatrix Plus — COOK BIOTECH INCORPORATED
- DynaMatrix Plus — 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 74257dd0-f8ed-4258-a147-9fdd1c1eb373 37 fields · synced May 30, 2026