Single-use drill bit
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- 4.5 mm Cannulated Drill Bit, TORQ TNT FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Single-use drill bit EUDAMED4.5 mm Cannulated Drill Bit, TORQ TNT FDA UDI
- Model / Reference
- 400426-006 EUDAMED400426-002 EUDAMED501765 EUDAMEDFDA UDI400426-003 EUDAMED
- Description
- 4.5 mm Cannulated Drill Bit, TORQ TNT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810055523276 EUDAMED00810055523047 EUDAMED00810055523603 EUDAMEDFDA UDI00810055523078 EUDAMED
- Basic UDI-DI
- 081005552Drillbit2T EUDAMED
- Direct Marketing DI
- 00810055523276 EUDAMED00810055523047 EUDAMED00810055523078 EUDAMED
- 510(k) Number
- K241504 FDA UDI
- FDA Product Code
- OLO FDA UDIHTW FDA UDI
- EMDN Code
- P091303 ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Joint prosthesis implantation kit, single-use
Single-use drill bit by Si-Bone Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081005552Drillbit2T | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (5)
- EUDAMED 190bcb18-85d9-4980-b4e8-af3857fa1d92 61 fields · synced Jul 29, 2026
- EUDAMED 0df449b0-d7a6-4bcf-9627-5f94927c603f 61 fields · synced May 17, 2026
- EUDAMED 90e37a22-148a-41d5-b713-e3622ba6e5f0 61 fields · synced May 17, 2026
- EUDAMED 4543b5d5-6f7f-491a-99fc-07eda97a874a 61 fields · synced May 17, 2026
- FDA UDI 749cab47-4aaa-4798-b042-783038f9a1c2 35 fields · synced May 30, 2026