Identity
- Trade Name
- Cannulated Screw System + FDA UDI
- Generic Name
- Surgical countersink, single-use FDA UDI
- Device Name
- Instruments EUDAMEDCANN COUNTERSINK FOR 6.5/7.5MM HEADED CANN SCREW + / LARGE QC FDA UDI
- Model / Reference
- 03.333.214 EUDAMEDFDA UDI
- Description
- CANN COUNTERSINK FOR 6.5/7.5MM HEADED CANN SCREW + / LARGE QC FDA UDI
Identifiers
- Catalog Number
- 03.333.214 FDA UDI
- Primary DI / UDI-DI
- 00819917026740 EUDAMEDFDA UDI
- Basic UDI-DI
- 019644901457 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Surgical countersink, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic guidewire, reusable
Instruments by Tyber Medical — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 019644901457 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Tyber Medical
- EUDAMED SRN
- US-MF-000011350
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 7080f637-c322-4548-a2e0-5507f56f66c8 61 fields · synced Jul 9, 2026
- FDA UDI 7f36a869-e945-40a3-b74c-34699b357687 35 fields · synced May 30, 2026