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icotec Cervical Cage, Inserter Sleeve long, -
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 41-13-4Model Inserter Sleeve
by icotec ag
Identity
- Trade Name
- icotec Cervical Cage, Inserter Sleeve long, - EUDAMEDicotec Cervical Cage, Inserter Sleeve, long FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- icotec Cervical Cage, Inserter Sleeve, long FDA UDI
- Model / Reference
- Inserter Sleeve EUDAMED41-13-4 EUDAMEDFDA UDI
- Description
- icotec Cervical Cage, Inserter Sleeve, long FDA UDI
Identifiers
- Catalog Number
- 41-13-4 FDA UDI
- Primary DI / UDI-DI
- 07640172551400 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255iCSI00013R EUDAMED
- Direct Marketing DI
- 07640172551400 EUDAMED
- FDA Product Code
- MAX FDA UDIODP FDA UDI
- EMDN Code
- L1109 NEUROSURGERY AND SPINAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable 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 Cervical Cage, Inserter Sleeve long, - 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 | 764017255iCSI00013R | 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 5d640797-e056-42e5-9fcd-171574daf9d5 61 fields · synced Jun 19, 2026
- FDA UDI 55dbfb1c-394e-4f26-8974-808174125463 35 fields · synced May 30, 2026