Identity
- Trade Name
- SIGMA LCS HIGH PERFORMANCE FDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Device Name
- SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH NONCEMENTED SIZE 2-3 FDA UDI
- Model / Reference
- 9505-02-014 FDA UDI
- Description
- SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH NONCEMENTED SIZE 2-3 FDA UDI
Identifiers
- Catalog Number
- 950502014 FDA UDI
- Primary DI / UDI-DI
- 10603295227342 FDA UDI
- FDA Product Code
- LRY FDA UDI
- GMDN Term
- Orthopaedic broach FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Sigma Lcs High Performance by Depuy Orthopaedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI ab5e24c2-0512-4c0d-8838-ec84dcf83d79 36 fields · synced Jun 8, 2026