Identity
- Trade Name
- 10.5 mm Drill, Cannulated, Nav FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Navigated drill bit EUDAMED10.5 mm Drill, Cannulated, Nav FDA UDI
- Model / Reference
- 501122-1050 EUDAMEDFDA UDI
- Description
- 10.5 mm Drill, Cannulated, Nav FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855369008408 EUDAMEDFDA UDI
- Basic UDI-DI
- 081005552DrillbitNavQA EUDAMED
- Direct Marketing DI
- 00855369008408 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L1104 BITS FOR NEUROSURGERY DRILLS, REUSABLE EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany 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
No
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
Navigated drill bit by Si-Bone Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081005552DrillbitNavQA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SI-BONE, Inc.
- EUDAMED SRN
- US-MF-000028624
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED 69fb39e7-e3e7-4403-a69c-60f3adeb0217 61 fields · synced Jul 25, 2026
- FDA UDI 33bc60b5-e7f2-46c4-92f7-de9925e92556 34 fields · synced May 29, 2026