Identity
- Trade Name
- NPWT Antimicrobial Large Gauze Roll FDA UDI
- Generic Name
- Woven gauze roll/sheet FDA UDI
- Device Name
- NPWT Antimicrobial Large Gauze Roll FDA UDI
- Model / Reference
- 66800391 FDA UDI
- Description
- NPWT Antimicrobial Large Gauze Roll FDA UDI
Identifiers
- Catalog Number
- 66800391 FDA UDI
- Primary DI / UDI-DI
- 00040565124223 FDA UDI
- 510(k) Number
- K142979 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Woven gauze roll/sheet FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
MR Unsafe FDA UDI
Category: Woven gauze roll/sheet
NPWT Antimicrobial Large Gauze Roll by Smith & Nephew Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142979 also covers:
- ANTIMICROBIAL GAUZE — Smith & Nephew Medical, Ltd.
- FOAM WOUND DRESSING — Smith & Nephew Medical, Ltd.
- Foam 10x12.5cm Pack 1 — Smith & Nephew Medical, Ltd.
- RENASYS F LARGE W/SOFT PORT — Smith & Nephew Medical, Ltd.
- RENASYS F MEDIUM W/SOFT PORT — Smith & Nephew Medical, Ltd.
- RENASYS F SMALL W/SOFT PORT — Smith & Nephew Medical, Ltd.
- Renasys — Smith & Nephew Medical, Ltd.
- Renasys — Smith & Nephew Medical, Ltd.
- Renasys — Smith & Nephew Medical, Ltd.
- Renasys — Smith & Nephew Medical, Ltd.
- Renasys — Smith & Nephew Medical, Ltd.
- Renasys — Smith & Nephew Medical, Ltd.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew Medical, Ltd.
Sources (1)
- FDA UDI f11408e7-3429-4aba-a14e-7fc827b25e79 35 fields · synced May 30, 2026