Identity
- Trade Name
- RENaSYS G SMaLL W/SOFT PORT FDA UDI
- Generic Name
- Wound dressing kit, medicated FDA UDI
- Device Name
- RENASYS G GAUZE Dressing Kit with Soft Port Small FDA UDI
- Model / Reference
- 66800933 FDA UDI
- Description
- RENASYS G GAUZE Dressing Kit with Soft Port Small FDA UDI
Identifiers
- Catalog Number
- 66800933 FDA UDI
- Primary DI / UDI-DI
- 00040565125718 FDA UDI
- 510(k) Number
- K162129 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
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
Category: Wound dressing kit, medicated
RENaSYS G SMaLL W/SOFT PORT by Smith & Nephew Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Wound dressing kit, medicated.
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Cleared under the same submission
K162129 also covers:
- RENASYS G LARGE W/SOFT PORT — Smith & Nephew Medical, Ltd.
- RENASYS G MEDIUM W/SOFT PORT — Smith & Nephew Medical, Ltd.
- RENASYS G SMALL W/SOFT PORT — Smith & Nephew Medical, Ltd.
- RENASYS G X-LARGE W/SOFT PORT — Smith & Nephew Medical, Ltd.
- RENaSYS G LaRGE W/SOFT PORT — Smith & Nephew Medical, Ltd.
- RENaSYS G MEDIUM W/SOFT PORT — Smith & Nephew Medical, Ltd.
- RENaSYS G XL W/SOFT PORT — 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 |
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Manufacturer
- Manufacturer
- Smith & Nephew Medical, Ltd.
Sources (1)
- FDA UDI 512035f5-d710-49ce-a3e9-17f2f161ac17 35 fields · synced May 30, 2026