Identity
- Trade Name
- LUCEA LED® FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- LCA50 UPGRADE 24V FDA UDI
- Model / Reference
- ARDLCA506001A FDA UDI
- Description
- LCA50 UPGRADE 24V FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700712404673 FDA UDI
- 510(k) Number
- K113679 FDA UDI
- FDA Product Code
- NTN FDA UDIFTD FDA UDI
- GMDN Term
- Operating room light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI878.4580 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
MR Unsafe FDA UDI
Lucea Led® by Maquet, Inc. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maquet, Inc.
Sources (1)
- FDA UDI 566196b7-0075-42fb-8eed-6c8c7dc66f0e 35 fields · synced Jun 6, 2026