Identity
- Trade Name
- ColActive Plus Powder Ag Wound Filler FDA UDI
- Generic Name
- Cavity-wound management dressing, antimicrobial FDA UDI
- Device Name
- ColActive Plus Powder Ag Wound Filler FDA UDI
- Model / Reference
- 10160002 FDA UDI
- Description
- ColActive Plus Powder Ag Wound Filler FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04052199578729 FDA UDI
- 510(k) Number
- K060804 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Cavity-wound management dressing, antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- 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
Category: Cavity-wound management dressing, antimicrobial
ColActive Plus Powder Ag Wound Filler by Hartmann Usa Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cavity-wound management dressing, antimicrobial.
- SiliGentle AG Silver Silicone Foam Dressing — Dynarex Corp. · U
- Silverlon Antimicrobial Wound Dressing — ARGENTUM MEDICAL, LLC · U
- DynaGinate AG Silver Calcium Alginate Rope Dressing — Dynarex Corp. · U
- SiliGentle AG Silver Silicone Foam Dressing — Dynarex Corp. · U
- Silverlon Antimicrobial Wound Dressing — ARGENTUM MEDICAL, LLC · U
- DynaFoam AG Silver Foam Dressing, Bordered — Dynarex Corp. · U
- SiliGentle AG Silver Silicone Foam Dressing — Dynarex Corp. · U
- CALICO — Calico Medical Group LLC · U
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
- Hartmann Usa Inc.
Sources (1)
- FDA UDI 55f57e5e-ed35-4ab8-8904-28bd22852023 34 fields · synced May 30, 2026