SIGMA LCS High Performance INSTRUMENTS
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- SIGMA LCS High Performance INSTRUMENTS EUDAMEDSIGMA LCS HIGH PERFORMANCE FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- Threaded/Fixation Pin EUDAMEDSIGMA LCS HIGH PERFORMANCE INSTRUMENTS STERILE THREADED PINS FDA UDI
- Model / Reference
- Sigma High Performance Fixation Pin EUDAMED9505-02-302 EUDAMEDFDA UDI
- Description
- SIGMA LCS HIGH PERFORMANCE INSTRUMENTS STERILE THREADED PINS FDA UDI
Identifiers
- Catalog Number
- 950502302 FDA UDI
- Primary DI / UDI-DI
- 10603295228905 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a005579C EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- Z12139085 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - CONSUMABLES 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
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Orthopaedic guidewire, single-use
SIGMA LCS High Performance INSTRUMENTS by DePuy Ireland UC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, single-use.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP. · Class II
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP. · Class II
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- 2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc · Class I
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- Ball Tip Wire — Orthopedic Designs North America, Inc. · Class I
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0603295a005579C | 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 86905ad8-4262-465a-80f6-3fb360d1582e 61 fields · synced Jul 9, 2026
- FDA UDI 4763f2e4-036a-4b52-909f-8ab79b182409 35 fields · synced May 29, 2026