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Short Screw Hex Driver (3.5mm)
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-1077Model INS-1075
by OrthoXel DAC
Identity
- Trade Name
- Short Screw Hex Driver (3.5mm) EUDAMEDApex FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Short Screw Hex Driver (3.5mm) EUDAMEDFDA UDIHex Driver (5mm/8mm) EUDAMED
- Model / Reference
- INS-1077 EUDAMEDFDA UDIINS-1075 EUDAMED
- Description
- Short Screw Hex Driver (3.5mm) FDA UDI
Identifiers
- Catalog Number
- INS-1077 FDA UDI
- Primary DI / UDI-DI
- 05391529582876 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529582876 EUDAMED539152958285278 EUDAMED
- Direct Marketing DI
- 05391529582876 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
Short Screw Hex Driver (3.5mm) 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-05391529582876 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05391529582876 | 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 c480fa95-ed7a-4885-9a82-e6ea8e59b08f 61 fields · synced Jul 24, 2026
- EUDAMED 8723f49f-8259-40ff-8f4d-45f7b6db3e82 61 fields · synced May 19, 2026
- FDA UDI d39e89c4-f94d-4c35-8ddb-edf9739e0063 36 fields · synced May 30, 2026