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6401-90213
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 6401-90213Model Canyon Retractor Systems Disposable Illuminator – 91.4cm
Identity
- Trade Name
- K2M Canyon Retractor Systems FDA UDI
- Generic Name
- Open surgical site internal light FDA UDI
- Model / Reference
- Canyon Retractor Systems Disposable Illuminator – 91.4cm EUDAMED6401-90213 EUDAMED012219 FDA UDI
Identifiers
- Catalog Number
- 6401-90213 FDA UDI
- Primary DI / UDI-DI
- 00812432021610 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00812432021610 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
- France 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
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
6401-90213 by Lumitex Medical Devices, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00812432021610 | 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 af7dbbe4-f34f-4fcc-b372-1fbccf3e01d0 61 fields · synced Jun 17, 2026
- FDA UDI dbddc199-175b-4472-87ed-08906decdac2 33 fields · synced May 30, 2026