Identity
- Trade Name
- ENDOLIGHT FDA UDI
- Generic Name
- Endoscopic light source unit, line-powered FDA UDI
- Device Name
- LIGHT SOURCE LED 1.3 76W LED, low operating noise level, dialog function, touch screen, color display, compatible with core, universal light cable connection, 6500K, U: 100-240VAC, 50/60Hz FDA UDI
- Model / Reference
- 5162001 FDA UDI
- Description
- LIGHT SOURCE LED 1.3 76W LED, low operating noise level, dialog function, touch screen, color display, compatible with core, universal light cable connection, 6500K, U: 100-240VAC, 50/60Hz FDA UDI
Identifiers
- Catalog Number
- 5162001 FDA UDI
- Primary DI / UDI-DI
- 04055207012956 FDA UDI
- FDA Product Code
- NTN FDA UDI
- GMDN Term
- Endoscopic light source unit, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Endolight by Richard Wolf GmbH — 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
- Richard Wolf GmbH
Sources (1)
- FDA UDI 7a3974ba-fa7e-46e7-bd7f-f9a63870ad82 36 fields · synced May 30, 2026