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Yellow Ø4.25mm Twist Drill X Length 300mm (Use Ø5.00mm Locking Screw)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref INS-1129
by OrthoXel DAC
Identity
- Trade Name
- Yellow Ø4.25mm Twist Drill X Length 300mm (Use Ø5.00mm Locking Screw) EUDAMEDApex FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Yellow Ø4.25mm Twist Drill X Length 300mm (Use Ø5.00mm Locking Screw) EUDAMEDFDA UDI
- Model / Reference
- INS-1129 EUDAMEDFDA UDI
- Description
- Yellow Ø4.25mm Twist Drill X Length 300mm (Use Ø5.00mm Locking Screw) FDA UDI
Identifiers
- Catalog Number
- INS-1129 FDA UDI
- Primary DI / UDI-DI
- 05391529583095 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529583095 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yellow Ø4.25mm Twist Drill X Length 300mm (Use Ø5.00mm Locking Screw) by OrthoXel DAC — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05391529583095 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (2)
- EUDAMED 594dc89a-d871-4155-afd8-64ebee1978a9 61 fields · synced Jun 19, 2026
- FDA UDI 609c8825-a091-488a-8015-a6d98486f86a 37 fields · synced May 29, 2026