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icotec Lumbar Cage Nerve Root Retractor 10 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 38-034-10Model Nerve Root Retractor
by icotec ag
Identity
- Trade Name
- icotec Lumbar Cage Nerve Root Retractor 10 mm EUDAMEDicotec Lumbar Cage, Nerve Root Retractor, 10 mm FDA UDI
- Generic Name
- Nerve/vessel retractor FDA UDI
- Device Name
- icotec Lumbar Cage, Nerve Root Retractor, 10 mm FDA UDI
- Model / Reference
- Nerve Root Retractor EUDAMED38-034-10 EUDAMEDFDA UDI
- Description
- icotec Lumbar Cage, Nerve Root Retractor, 10 mm FDA UDI
Identifiers
- Catalog Number
- 38-034-10 FDA UDI
- Primary DI / UDI-DI
- 07640164841823 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255iLCAGE00098M EUDAMED
- Direct Marketing DI
- 07640164841823 EUDAMED
- FDA Product Code
- MAX FDA UDIODP FDA UDI
- EMDN Code
- L1111 NEUROSURGERY MANIPULATORS, REUSABLE EUDAMED
- GMDN Term
- Nerve/vessel retractor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
icotec Lumbar Cage Nerve Root Retractor 10 mm by icotec AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764017255iLCAGE00098M | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- icotec ag
- EUDAMED SRN
- CH-MF-000026833
- Authorised Representative
- icotec Medical GmbH DE-AR-000016837
Sources (2)
- EUDAMED 13abae4d-2632-46bd-89d6-a6138c481cfa 61 fields · synced Jun 18, 2026
- FDA UDI 1b44e0b9-fb4c-4e20-915d-2a5d1eb49fd8 35 fields · synced May 30, 2026