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-STER FDA UDI
- Model / Reference
- 03.333.214S EUDAMEDFDA UDI
- Description
- CANN COUNTERSINK FOR 6.5/7.5MM HEADED CANN SCREW + / LARGE QC-STER FDA UDI
Identifiers
- Catalog Number
- 03.333.214S FDA UDI
- Primary DI / UDI-DI
- 00819917026849 EUDAMEDFDA UDI
- Basic UDI-DI
- 019644901457 EUDAMED
- FDA Product Code
- HWC 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 II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic guidewire, reusable
Instruments by Tyber Medical — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, reusable.
- Orthopaedic Spreader — Synthes GmbH · Class IIa
- LCP — Synthes GmbH · Class IIa
- Guide Wire — I.T.S. GmbH · Class I
- Parallel Wire Guide, for φ2.5 Guide Wire, Adjustable — Double Medical Technology Inc. · Class II
- VERTECEM — Synthes GmbH · Class IIa
- Adapter Fibre Optic Cable Light Cable — Synthes GmbH · Class I
- ZERO-P — Synthes GmbH · Class IIa
- Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tyber Medical
- EUDAMED SRN
- US-MF-000011350
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 95a8bac0-fed1-43aa-b879-403cd4ea383d 61 fields · synced May 30, 2026
- FDA UDI 12f406c2-0dd1-4a8e-ad22-76f0f37b543e 35 fields · synced May 30, 2026