Identity
- Trade Name
- Kirschner Wire EUDAMEDKischner wire FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Kirschner Wire EUDAMEDBlunt-tipped Kirschner wire (rounded tip) designed to guide the countersink phase without disturbing the cortex. FDA UDI
- Model / Reference
- ATMWCIN28 EUDAMED21 FDA UDI
- Description
- Blunt-tipped Kirschner wire (rounded tip) designed to guide the countersink phase without disturbing the cortex. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437019739409 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08437019739409 EUDAMED
- FDA Product Code
- KIL FDA UDI
- EMDN Code
- P09120301 KIRSCHNER BONE WIRES EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone pin, non-bioabsorbable
Kirschner Wire by Abanza Tecnomed, S.l. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone pin, non-bioabsorbable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08437019739409 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Abanza Tecnomed, S.l.
- EUDAMED SRN
- ES-MF-000007530
Sources (2)
- EUDAMED c320eac4-279b-4c23-86b1-26169d53ef42 61 fields · synced Jul 25, 2026
- FDA UDI 18babd03-4a0d-46b7-b20d-8291e768bf1e 34 fields · synced May 27, 2026