Identity
- Trade Name
- PROFORE LITE SYSTEM KIT Case 8 FDA UDI
- Generic Name
- Wound dressing kit, non-medicated FDA UDI
- Device Name
- Lite Multi-layer Compression Bandage System FDA UDI
- Model / Reference
- 66000415 FDA UDI
- Description
- Lite Multi-layer Compression Bandage System FDA UDI
Identifiers
- Catalog Number
- 66000415 FDA UDI
- Primary DI / UDI-DI
- 05031844002498 FDA UDI
- FDA Product Code
- FQM FDA UDI
- GMDN Term
- Wound dressing kit, non-medicated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 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
Yes
FDA UDI
Prescription Use
No
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
Yes
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, non-medicated
PROFORE LITE SYSTEM KIT Case 8 by Smith & Nephew Medical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Smith & Nephew Medical, Ltd.
Sources (1)
- FDA UDI adec5d44-1136-43ef-b4ad-7b8c27f4fc92 34 fields · synced Jun 1, 2026