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Stabilok Twist Drill
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ORANGE DOModel STABILOK TWIST DRILL
Identity
- Trade Name
- STABILOK TWIST DRILL EUDAMEDStabilok drill FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- STABILOK TWIST DRILL ORANGE EUDAMEDTwist drill FDA UDI
- Model / Reference
- STABILOK TWIST DRILL EUDAMEDORANGE DO EUDAMEDDrill Orange FDA UDI
- Description
- Twist drill FDA UDI
Identifiers
- Catalog Number
- DO FDA UDI
- Primary DI / UDI-DI
- 05060489370099 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060489370099 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.68 Millimeter FDA UDI
Stabilok Twist Drill by Fairfax Medical Products Limited — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-05060489370099 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Fairfax Medical Products Limited
- EUDAMED SRN
- GB-MF-000025334
- Authorised Representative
- MD REPS Ltd XI-AR-000040375
Sources (2)
- EUDAMED 439a03ec-4d0b-46ac-9742-0439b3446ae4 61 fields · synced Jul 12, 2026
- FDA UDI 06032cae-16fc-4dcc-af3e-9f0984cd3974 36 fields · synced May 30, 2026