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Short Screw Driver With Retention Hex (3.5mm) [A&B]
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-1076Model INS-1075
by OrthoXel DAC
Identity
- Trade Name
- Short Screw Driver With Retention Hex (3.5mm) [A&B] EUDAMEDShort Screw Driver With Retention Hex (3.5mm) EUDAMEDApex FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Short Screw Driver With Retention Hex (3.5mm) [A&B] EUDAMEDHex Driver (5mm/8mm) EUDAMEDShort Screw Driver With Retention Hex (3.5mm) FDA UDI
- Model / Reference
- INS-1076 EUDAMEDFDA UDIINS-1075 EUDAMED
- Description
- Short Screw Driver With Retention Hex (3.5mm) FDA UDI
Identifiers
- Catalog Number
- INS-1076 FDA UDI
- Primary DI / UDI-DI
- 05391529582869 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529582869 EUDAMED539152958285278 EUDAMED
- Direct Marketing DI
- 05391529582869 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
Short Screw Driver With Retention Hex (3.5mm) [A&B] 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-05391529582869 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05391529582869 | 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 e84c9a63-b98c-4664-b1b7-3d457ef9ff0d 61 fields · synced Jul 14, 2026
- EUDAMED f031b0b0-9613-4eb4-8545-104ddb6e22d0 61 fields · synced May 18, 2026
- FDA UDI 97782832-1c59-4059-8333-2165ee1b5a84 36 fields · synced May 30, 2026