Identity
- Trade Name
- 3.2 mm Drill Bit Short FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Twist Drill, 5/16” EUDAMED3.2 mm Drill Bit Short FDA UDI
- Model / Reference
- 11-141-000 EUDAMEDFDA UDI
- Description
- 3.2 mm Drill Bit Short FDA UDI
Identifiers
- Catalog Number
- 2500-00-766 FDA UDI
- Primary DI / UDI-DI
- 00847538007626 EUDAMEDFDA UDI
- Basic UDI-DI
- 08475380323902Y EUDAMED
- Direct Marketing DI
- 00847538007626 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 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
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
Twist Drill, 5/16” by Symmetry Medical Manufacturing, Inc. — Class IIa — 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 | 08475380323902Y | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Symmetry Medical Manufacturing, Inc.
- EUDAMED SRN
- US-MF-000025394
- Authorised Representative
- SYMMETRY MEDICAL POLYVAC FR-AR-000003187
Sources (2)
- EUDAMED 753773fb-d21b-48dc-b978-8fef5afe1525 61 fields · synced Oct 7, 2026
- FDA UDI 324400d7-a48c-47af-a5c5-95dc65308770 34 fields · synced May 27, 2026