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Flexible Hex Driver Ball Tip (5mm/8mm)
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-1151Model INS-1108
by OrthoXel DAC
Identity
- Trade Name
- Flexible Hex Driver Ball Tip (5mm/8mm) EUDAMEDApex FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- 3.5mm Hex Short Driver Shaft EUDAMEDFlexible Hex Driver Ball Tip (5mm/8mm) EUDAMEDFDA UDI
- Model / Reference
- INS-1108 EUDAMEDINS-1151 EUDAMEDFDA UDI
- Description
- Flexible Hex Driver Ball Tip (5mm/8mm) FDA UDI
Identifiers
- Catalog Number
- INS-1151 FDA UDI
- Primary DI / UDI-DI
- 05391529588656 EUDAMEDFDA UDI
- Basic UDI-DI
- 539152958517474 EUDAMEDB-05391529588656 EUDAMED
- Direct Marketing DI
- 05391529588656 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 UDIClass IIa EUDAMED
- 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
Flexible Hex Driver Ball Tip (5mm/8mm) 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 | 539152958517474 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 539152958517474 | 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 d0189f0f-9f3b-44dc-b816-481d077fdb51 61 fields · synced Jul 9, 2026
- EUDAMED 411ac379-a5b8-4fca-8c73-a112aaecfc96 61 fields · synced May 19, 2026
- FDA UDI d1b8a965-8a42-41ca-a54b-5e2d1cdfa6a2 37 fields · synced May 25, 2026