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icotec Lumbar Cage Probe, PLIF 0°, 7 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 38-010-007Model Probe
by icotec ag
Identity
- Trade Name
- icotec Lumbar Cage Probe, PLIF 0°, 7 mm EUDAMEDicotec Lumbar Cage, Probe, PLIF, 0°, 7 mm FDA UDI
- Generic Name
- Orthopaedic surgical distractor, internal FDA UDI
- Device Name
- icotec Lumbar Cage, Probe, PLIF, 0°, 7 mm FDA UDI
- Model / Reference
- Probe EUDAMED38-010-007 EUDAMEDFDA UDI
- Description
- icotec Lumbar Cage, Probe, PLIF, 0°, 7 mm FDA UDI
Identifiers
- Catalog Number
- 38-010-007 FDA UDI
- Primary DI / UDI-DI
- 07640164841410 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255iLCAGE000287 EUDAMED
- Direct Marketing DI
- 07640164841410 EUDAMED
- FDA Product Code
- MAX FDA UDIODP FDA UDI
- EMDN Code
- L1109 NEUROSURGERY AND SPINAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic surgical distractor, internal 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
No
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 Probe, PLIF 0°, 7 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 | 764017255iLCAGE000287 | 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 63fe5a4e-eae6-49ee-ab06-8cd7d4e06146 61 fields · synced Jul 13, 2026
- FDA UDI e9d9d0d3-421d-42f1-a012-86ab280ca069 35 fields · synced May 29, 2026