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Long Removal and Insertion Hex (5mm)
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-1136Model INS-1108
by OrthoXel DAC
Identity
- Trade Name
- Long Removal and Insertion Hex (5mm) EUDAMEDApex FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- 3.5mm Hex Short Driver Shaft EUDAMEDLong Removal and Insertion Hex (5mm EUDAMEDLong Removal and Insertion Hex (5mm) FDA UDI
- Model / Reference
- INS-1108 EUDAMEDINS-1136 EUDAMEDFDA UDI
- Description
- Long Removal and Insertion Hex (5mm) FDA UDI
Identifiers
- Catalog Number
- INS-1136 FDA UDI
- Primary DI / UDI-DI
- 05391529581855 EUDAMEDFDA UDI
- Basic UDI-DI
- 539152958517474 EUDAMEDB-05391529581855 EUDAMED
- Direct Marketing DI
- 05391529581855 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Long Removal and Insertion Hex (5mm) 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 3bbbb7fd-17a2-4f73-8b9c-56e3c67d7fc1 61 fields · synced Sep 18, 2026
- EUDAMED 995f248d-af43-4d11-8454-16df7886c007 61 fields · synced May 19, 2026
- FDA UDI 527ea071-297f-4aa5-b961-f903456473c1 36 fields · synced May 30, 2026