Identity
- Trade Name
- Combination Wrench EUDAMEDApex FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Device Name
- Combination Wrench EUDAMEDFDA UDI
- Model / Reference
- INS-1010 EUDAMEDFDA UDI
- Description
- Combination Wrench FDA UDI
Identifiers
- Catalog Number
- INS-1010 FDA UDI
- Primary DI / UDI-DI
- 05391529582234 EUDAMEDFDA UDI
- Basic UDI-DI
- 539152958223468 EUDAMEDB-05391529582234 EUDAMED
- Direct Marketing DI
- 05391529582234 EUDAMED
- FDA Product Code
- HXC FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER 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
- Ireland 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Combination Wrench by OrthoXel DAC — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 539152958223468 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 539152958223468 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (3)
- EUDAMED deec29e2-b38c-4c67-9b40-52a254ba6c02 61 fields · synced Aug 2, 2026
- EUDAMED fd5beb84-ab48-4ef5-b1de-04d94cf5a44d 61 fields · synced May 19, 2026
- FDA UDI ab6b80a2-3e8e-4edb-825a-7d02d340f24e 36 fields · synced May 30, 2026