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Driver With Retention Hex (5mm)
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-1059
by OrthoXel DAC
Identity
- Trade Name
- Driver With Retention Hex (5mm) EUDAMEDApex FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Driver With Retention Hex (5mm) EUDAMEDFDA UDI
- Model / Reference
- INS-1059 EUDAMEDFDA UDI
- Description
- Driver With Retention Hex (5mm) FDA UDI
Identifiers
- Catalog Number
- INS-1059 FDA UDI
- Primary DI / UDI-DI
- 05391529582722 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529582722 EUDAMED53915295827226S EUDAMED
- Direct Marketing DI
- 05391529582722 EUDAMED
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Driver With Retention Hex (5mm) by OrthoXel DAC — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05391529582722 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05391529582722 | 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 eb4e6dae-8ba3-496e-b2b6-7a1a247692ca 61 fields · synced Jun 8, 2026
- EUDAMED 9abed20c-538b-4a7d-b661-09dc9992c506 61 fields · synced May 19, 2026
- FDA UDI 4cf80e74-5630-4b38-bd31-7ed8a3518843 36 fields · synced May 30, 2026