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Double Open-End Wrench (10 X 14 Mm)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 52424
by Brainlab SE
Identity
- Trade Name
- DOUBLE OPEN-END WRENCH (10 X 14 MM) EUDAMEDDouble Open-End Wrench (10 x 14 mm) FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Device Name
- Wrench EUDAMED
- Model / Reference
- 52424 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 52424 FDA UDI
- Primary DI / UDI-DI
- 04056481005979 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481WrenchR7 EUDAMED
- Direct Marketing DI
- 04056481005979 EUDAMED
- FDA Product Code
- HXC FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical torque wrench, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Double Open-End Wrench (10 X 14 Mm) by Brainlab SE — 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 | 4056481WrenchR7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 8dbfaa57-a9f1-405e-968b-9f2e667c00f1 61 fields · synced Jul 17, 2026
- FDA UDI 9b9ae518-d646-4004-9493-1058013b65bd 34 fields · synced May 30, 2026