Identity
- Trade Name
- SIGMA EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- DRILL EUDAMEDSIGMA SP2 FEM LUG DRILL W/HUDSON END FDA UDI
- Model / Reference
- SROM DRILL EUDAMED96-6202 EUDAMEDFDA UDI
- Description
- SIGMA SP2 FEM LUG DRILL W/HUDSON END FDA UDI
Identifiers
- Catalog Number
- 966202 FDA UDI
- Primary DI / UDI-DI
- 10603295247272 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a002188K EUDAMED
- Direct Marketing DI
- 10603295247272 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 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
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
No
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
Category: Acetabular orthopaedic reamer
Sigma by DePuy Ireland UC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Acetabular orthopaedic reamer.
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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 | 0603295a002188K | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 522779ce-e6bb-4412-9cb6-e9f81868148a 61 fields · synced Jul 15, 2026
- FDA UDI 19777049-38e6-4c5b-bb72-a299547edf2e 35 fields · synced May 30, 2026