Identity
- Trade Name
- Positioner Guide EUDAMEDFDA UDI
- Generic Name
- Orthopaedic reamer guide FDA UDI
- Device Name
- Positioner Guide EUDAMEDCannulated instrument that is placed on the positioner (once it has been introduced into the tunnel) to pass a Ø2.4 mm Kirschner wire through it that will serve to guide the countersink of the cortex. FDA UDI
- Model / Reference
- ATMWCIN79 EUDAMED21 FDA UDI
- Description
- Cannulated instrument that is placed on the positioner (once it has been introduced into the tunnel) to pass a Ø2.4 mm Kirschner wire through it that will serve to guide the countersink of the cortex. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437019739348 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08437019739348 EUDAMED
- FDA Product Code
- KIL FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic reamer guide 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 implant impactor, reusable
Positioner Guide by Abanza Tecnomed, S.l. — Class I — MDD, 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/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08437019739348 | 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 368b7beb-2335-4120-adab-6e4742277ec0 61 fields · synced Jun 18, 2026
- FDA UDI 621a8dfb-25c2-47fe-abca-da1097223a62 34 fields · synced May 30, 2026