Identity
- Trade Name
- Countersink Tool EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Countersink tool EUDAMEDTool used to thread and unscrew the top of the countersink body for easy disassembly. FDA UDI
- Model / Reference
- ATMWCIN78 EUDAMED21 FDA UDI
- Description
- Tool used to thread and unscrew the top of the countersink body for easy disassembly. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437019739331 EUDAMEDFDA UDI
- Basic UDI-DI
- 8437019739ATMWCIN7836 EUDAMED
- Direct Marketing DI
- 08437019739331 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Surgical screwdriver, 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Countersink Tool by Abanza Tecnomed, S.l. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 8437019739ATMWCIN7836 | 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 4089141d-5bba-456b-8da5-ce46a95e1e77 61 fields · synced Jun 19, 2026
- FDA UDI 4ec89cb1-5d63-4d30-8d29-cecd58d90219 34 fields · synced May 30, 2026