Identity
- Trade Name
- LEXER OSTEOTOME FDA UDI
- Generic Name
- Orthopaedic osteotome handle FDA UDI
- Device Name
- LEXER OSTEOTOME MINIATURE PHENOLIC HANDLE FDA UDI
- Model / Reference
- 330-015 FDA UDI
- Description
- LEXER OSTEOTOME MINIATURE PHENOLIC HANDLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896101425 FDA UDI
- FDA Product Code
- HWM FDA UDI
- GMDN Term
- Orthopaedic osteotome handle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Dimensions & Sizes
- Size
- Length — 8.75 Inch FDA UDI
Category: Orthopaedic osteotome handle
Lexer Osteotome by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 1030e5a9-6452-4069-a663-9e9bb1f5675f 35 fields · synced Jun 6, 2026