Identity
- Trade Name
- RENASYS FDA UDI
- Generic Name
- Wound dressing kit, medicated FDA UDI
- Device Name
- RENASYS Gauze Large Wound Dressing Kit with AIRLOCK Technology and Soft Port FDA UDI
- Model / Reference
- 66803113 FDA UDI
- Description
- RENASYS Gauze Large Wound Dressing Kit with AIRLOCK Technology and Soft Port FDA UDI
Identifiers
- Catalog Number
- 66803113 FDA UDI
- Primary DI / UDI-DI
- 05000223499136 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Wound dressing kit, medicated 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
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
MR Safe FDA UDI
Category: Wound dressing kit, medicated
Renasys by Smith & Nephew Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound dressing kit, medicated.
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
- Stradis Medical, LLC. — STRADIS MEDICAL, LLC · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
- Stradis Medical, LLC. — STRADIS MEDICAL, LLC · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
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 4914009d-4526-4b70-8fd4-8e3fa4b7f9c3 37 fields · synced May 30, 2026