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Ac01-90046
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AC01-90046Model Niagara Lateral Access System Bifurcated Illuminator – 91.4cm
Identity
- Trade Name
- K2M - NIAGARA Lateral Access System Bifurcated Illuminator FDA UDI
- Generic Name
- Open surgical site internal light FDA UDI
- Model / Reference
- Niagara Lateral Access System Bifurcated Illuminator – 91.4cm EUDAMEDAC01-90046 EUDAMED011846 FDA UDI
Identifiers
- Catalog Number
- AC01-90046 FDA UDI
- Primary DI / UDI-DI
- 00812432020682 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00812432020682 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
- Italy 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
Category: Surgical retractor/retraction system blade, single-use
Ac01-90046 by Lumitex Medical Devices, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical retractor/retraction system blade, single-use.
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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-00812432020682 | 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 c9ad8ae5-6cf0-4be0-911f-6f88e608bbb2 61 fields · synced Jul 26, 2026
- FDA UDI 56481589-3b66-48c8-9815-3019c46ae228 33 fields · synced May 30, 2026