Identity
- Trade Name
- LCP FDA UDI
- Generic Name
- Orthopaedic medialization instrument FDA UDI
- Device Name
- MEDIALIZATION GUIDE FOR 3.5MM & 5.0MM LCP PLATES FDA UDI
- Model / Reference
- 03.108.007 FDA UDI
- Description
- MEDIALIZATION GUIDE FOR 3.5MM & 5.0MM LCP PLATES FDA UDI
Identifiers
- Catalog Number
- 03108007 FDA UDI
- Primary DI / UDI-DI
- 10886982071576 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic medialization instrument FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- 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
Yes
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: Orthopaedic medialization instrument
Lcp by Synthes — 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
- Synthes
Sources (1)
- FDA UDI 51451f5a-cecb-4a9f-84b9-b1ef71c0db15 35 fields · synced May 31, 2026