Identity
- Trade Name
- BERMUDA GOLD PREMIUM PLUS / 160W FDA UDI
- Generic Name
- Ultraviolet tanning device FDA UDI
- Model / Reference
- FR71 T12 160W VHO PH / BiPin FDA UDI
Identifiers
- Catalog Number
- 16367 FDA UDI
- Primary DI / UDI-DI
- 04014501000762 FDA UDI
- FDA Product Code
- LEJ FDA UDI
- GMDN Term
- Ultraviolet tanning device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4635 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Bermuda Gold Premium Plus / 160w by NARVA Lichtquellen GmbH + Co KG. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- NARVA Lichtquellen GmbH + Co KG.
Sources (1)
- FDA UDI ce513f1c-62a4-47f1-8c66-3177b9225ccc 36 fields · synced May 31, 2026