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icotec Anterior Cervical Plate System Drill Sleeve for Template SW 4 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 39-20Model Drill Sleeve
by icotec ag
Identity
- Trade Name
- icotec Anterior Cervical Plate System Drill Sleeve for Template SW 4 mm EUDAMEDicotec Anterior Cervical Plate System, Drill Sleeve for Template, SW 4 mm FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- icotec Anterior Cervical Plate System, Drill Sleeve for Template, SW 4 mm FDA UDI
- Model / Reference
- Drill Sleeve EUDAMED39-20 EUDAMEDFDA UDI
- Description
- icotec Anterior Cervical Plate System, Drill Sleeve for Template, SW 4 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640140438801 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255iCPI00052S EUDAMED
- Direct Marketing DI
- 07640140438801 EUDAMED
- FDA Product Code
- KWQ FDA UDI
- EMDN Code
- L1109 NEUROSURGERY AND SPINAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic implantation sleeve, 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
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 Anterior Cervical Plate System Drill Sleeve for Template SW 4 mm by icotec AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 764017255iCPI00052S | 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 88173e7c-2221-42d0-93c7-41b10e8096c2 61 fields · synced Jul 8, 2026
- FDA UDI 997684ef-19e4-4092-81ba-2a590ebb6053 34 fields · synced May 29, 2026