Identity
- Trade Name
- ColActive® Transfer 4x4 FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Device Name
- Wound contact layer FDA UDI
- Model / Reference
- 5550441 FDA UDI
- Description
- Wound contact layer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00825439013472 FDA UDI
- 510(k) Number
- K123756 FDA UDI
- FDA Product Code
- KGN FDA UDI
- GMDN Term
- Animal-derived wound matrix dressing FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Dimensions & Sizes
- Size
- Length — 4 Inch FDA UDIWidth — 4 Inch FDA UDI
ColActive® Transfer 4x4 by Covalontechnologies, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 U | Pending data |
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Manufacturer
- Manufacturer
- Covalontechnologies, Inc.
Sources (1)
- FDA UDI b25073a5-caea-4b3e-9e89-96691bd0ebed 37 fields · synced May 31, 2026