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Sigma Lcs
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 9505-02-073Model SIGMA HIGH PERFORMANCE DRILL BIT/PIN
Identity
- Trade Name
- SIGMA LCS EUDAMEDSIGMA LCS FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- DRILL BIT/PIN EUDAMEDSIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE QUICK DRILL PINS HEADED FDA UDI
- Model / Reference
- SIGMA HIGH PERFORMANCE DRILL BIT/PIN EUDAMED9505-02-073 EUDAMEDFDA UDI
- Description
- SIGMA HIGH PERFORMANCE LCS HIGH PERFORMANCE QUICK DRILL PINS HEADED FDA UDI
Identifiers
- Catalog Number
- 950502073 FDA UDI
- Primary DI / UDI-DI
- 10603295227892 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0056295 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- P091303 ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE EUDAMED
- GMDN Term
- Fluted surgical drill bit, single-use 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
Yes
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: Joint prosthesis implantation kit, single-use
Sigma Lcs by DePuy Ireland UC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0603295a0056295 | 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 b5a46da2-2d56-408c-b37f-c76c0e1c46c4 61 fields · synced Jul 14, 2026
- FDA UDI 138b0882-eefe-4bc7-b0e1-e118a9d1f52f 35 fields · synced May 29, 2026