icotec Anterior Cervical Plate System Tap, AO Coupling Ø 4 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
by icotec ag
Identity
- Trade Name
- icotec Anterior Cervical Plate System Tap, AO Coupling Ø 4 mm EUDAMEDicotec Anterior Cervical Plate System, Tap, AO Coupling, 4 mm FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- icotec Anterior Cervical Plate System, Tap, AO Coupling, 4 mm FDA UDI
- Model / Reference
- Tap EUDAMED39-4 EUDAMEDFDA UDI
- Description
- icotec Anterior Cervical Plate System, Tap, AO Coupling, 4 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640140434483 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255iCPI00132R EUDAMED
- Direct Marketing DI
- 07640140434483 EUDAMED
- FDA Product Code
- KWQ FDA UDI
- EMDN Code
- L1109 NEUROSURGERY AND SPINAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
icotec Anterior Cervical Plate System Tap, AO Coupling Ø 4 mm by icotec AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764017255iCPI00132R | 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 c5355db4-9995-42e2-8ba6-bcb7ce2b29d9 61 fields · synced Jul 11, 2026
- FDA UDI 41b54263-43d1-4e70-9bd0-ea19d59fbc56 34 fields · synced May 30, 2026