Identity
- Trade Name
- ActivHeal FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- ACTIVHEAL GLOBAL SURGICAL AG 9X10CM FDA UDI
- Model / Reference
- Ag Postoperative Ionic Silver FDA UDI
- Description
- ACTIVHEAL GLOBAL SURGICAL AG 9X10CM FDA UDI
Identifiers
- Catalog Number
- 9025018 FDA UDI
- Primary DI / UDI-DI
- 15032749025015 FDA UDI
- 510(k) Number
- K180634 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, 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
Yes
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
No
FDA UDI
MR Unsafe FDA UDI
Category: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
ActivHeal by Advanced Medical Solutions Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Exudate-absorbent dressing, hydrophilic-gel, antimicrobial.
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Cleared under the same submission
K180634 also covers:
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED
- PRIMASEAL — MEDLINE INDUSTRIES, INC.
- PRIMASEAL — MEDLINE INDUSTRIES, INC.
- PRIMASEAL — MEDLINE INDUSTRIES, INC.
- PRIMASEAL — MEDLINE INDUSTRIES, INC.
- PRIMASEAL — MEDLINE INDUSTRIES, INC.
- PRIMASEAL Post-Op Ag — MEDLINE INDUSTRIES, 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
- Advanced Medical Solutions Limited
Sources (1)
- FDA UDI d2f16c45-8f21-4db1-9264-f65cd1164202 35 fields · synced Jun 7, 2026