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Surgical Illuminator - 2.5 Max Cable Diameter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 71-3040
Identity
- Trade Name
- Orthofix Surgical Illuminator FDA UDI
- Generic Name
- Open surgical site internal light FDA UDI
- Device Name
- Surgical Illuminator - 2.5 Max Cable Diameter EUDAMED
- Model / Reference
- 71-3040 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 010208 FDA UDI
- Primary DI / UDI-DI
- 00812432022655 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00812432022655 EUDAMED
- FDA Product Code
- FDG FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Open surgical site internal light FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.4530 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Surgical Illuminator - 2.5 Max Cable Diameter by Lumitex Medical Devices, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00812432022655 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Lumitex Medical Devices, Inc.
- EUDAMED SRN
- US-MF-000030520
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 250437fe-e21a-4206-a9a1-578be5336522 61 fields · synced Jun 17, 2026
- FDA UDI 27ff9a18-906f-421f-9641-a8e5c5d06342 33 fields · synced May 30, 2026