Lcs
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- LCS FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Instrument Handle C-I EUDAMEDLCS HIGH PERFORMANCE INSTRUMENTS IM ROD HANDLE FDA UDI
- Model / Reference
- 99-2011 EUDAMEDFDA UDIP.F.C. Instrument Handle C-I EUDAMED
- Description
- LCS HIGH PERFORMANCE INSTRUMENTS IM ROD HANDLE FDA UDI
Identifiers
- Catalog Number
- 992011 FDA UDI
- Primary DI / UDI-DI
- 10603295253778 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0004388 EUDAMED
- Direct Marketing DI
- 10603295253778 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
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
No
Manufacturing Date
No
Category: Surgical instrument handle, non-torque-limiting
Lcs by Depuy Orthopaedics, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (2)
- FDA UDI ceaa78aa-035f-4335-915f-d7fad8c027a8 35 fields · synced Jun 20, 2026
- EUDAMED a2adbda5-1b93-45e7-8dfc-65ba92816a08 61 fields · synced Jun 20, 2026