← Back to catalogue
SIGMA LCS High Performance
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 9505-02-026Model SROM DRILL
Identity
- Trade Name
- SIGMA LCS High Performance EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- DRILL EUDAMEDSIGMA LCS HIGH PERFORMANCE MBT CENTRAL DRILL NONCEMENTED FDA UDI
- Model / Reference
- SROM DRILL EUDAMED9505-02-026 EUDAMEDFDA UDI
- Description
- SIGMA LCS HIGH PERFORMANCE MBT CENTRAL DRILL NONCEMENTED FDA UDI
Identifiers
- Catalog Number
- 950502026 FDA UDI
- Primary DI / UDI-DI
- 10603295227465 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a002188K EUDAMED
- Direct Marketing DI
- 10603295227465 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 LCS High Performance by DePuy Ireland UC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetabular orthopaedic reamer.
- Acetabular Reamer Driver, Straight — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Viant Medical, LLC — Viant Medical, LLC · Class I
- ACETABULAR REAMER D53 mm HC — HPF SRL · Class I
- Flexible Reamer Ø14 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class I
- Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD · Class II
- ACETABULAR REAMER D82 mm HC — HPF SRL · Class I
- iTotal® Hip Replacement System — Conformis, Inc. · Class II
- U2 Total Knee System — United Orthopedic Corporation · Class IIa
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 2f2605bd-7b26-42b5-b8a4-14b919b93d47 61 fields · synced Jul 22, 2026
- FDA UDI 671b8ad7-d90a-4507-af60-4418e50f34f2 35 fields · synced May 30, 2026