Identity
- Trade Name
- ColActive® Plus Powder FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Device Name
- Collagen dressing FDA UDI
- Model / Reference
- 80P0001 FDA UDI
- Description
- Collagen dressing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00825439017241 FDA UDI
- 510(k) Number
- K060804 FDA UDI
- FDA Product Code
- FRO 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
- Weight — 1 Gram FDA UDI
ColActive® Plus Powder by Covalontechnologies, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K060804 also covers:
- ColActive® Plus 2"x2" — Covalontechnologies, Inc.
- ColActive® Plus 4"x4" — Covalontechnologies, Inc.
- ColActive® Plus 7"x7" — Covalontechnologies, Inc.
- ColActive® Plus Ag 2"x2" — Covalontechnologies, Inc.
- ColActive® Plus Ag 4"x4" — Covalontechnologies, Inc.
- ColActive® Plus Ag 7"x7" — Covalontechnologies, Inc.
- Zeni Medical — FOCUS HEALTH GROUP
- Zeni Medical — FOCUS HEALTH GROUP
- COLACTIVE PLUS 7x7 10/BX — HARTMANN USA INC.
- COLACTIVE PLUS AG 7x7 10/BX — HARTMANN USA INC.
- ColActive Plus 2x2 — HARTMANN USA INC.
- ColActive Plus 4x4 — HARTMANN USA INC.
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 3335439d-a8ea-40d0-87ac-38814ff986a8 37 fields · synced Jun 8, 2026