Identity
- Trade Name
- McKesson FDA UDI
- Generic Name
- Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
- Device Name
- Foam, PHMB ADH w/ Border Sacral FDA UDI
- Model / Reference
- 4977 FDA UDI
- Description
- Foam, PHMB ADH w/ Border Sacral FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00612479243392 FDA UDI
- 510(k) Number
- K181197 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, non-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
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
No
FDA UDI
Category: Exudate-absorbent dressing, non-gel, antimicrobial
McKesson by Mckesson Medical-Surgical Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exudate-absorbent dressing, non-gel, antimicrobial.
- MANUKAhd Lite 10 x 12.5 cm — MANUKAMED LIMITED PARTNERSHIP · U
- Areza Medical — ADVANCED MEDICAL ASSOCIATES, LLC · U
- ComfortFoam/Ag Border — DERMARITE INDUSTRIES LLC · U
- Medline — MEDLINE INDUSTRIES, INC. · U
- NuMed Industries LLC. — Numed Industries, LLC · U
- Arthrex® — Arthrex, Inc. · U
- CalciCare — Hollister Incorporated · U
- ComfortFoam/Ag Border — DERMARITE INDUSTRIES LLC · U
Cleared under the same submission
K181197 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
- 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
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
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI 14a763e3-e79e-488c-8c58-02891748c5fe 34 fields · synced May 30, 2026