Identity
- Trade Name
- SCHROM OSTEOTOME FDA UDI
- Generic Name
- Orthopaedic osteotome handle FDA UDI
- Device Name
- SCHROM OSTEOTOME WITH GUIDE CURVED FOR LEFT SIDE BLACK CERAMIC COATED FDA UDI
- Model / Reference
- 350-835LFB FDA UDI
- Description
- SCHROM OSTEOTOME WITH GUIDE CURVED FOR LEFT SIDE BLACK CERAMIC COATED FDA UDI
Identifiers
- Catalog Number
- 350-835LFB FDA UDI
- Primary DI / UDI-DI
- 00192896031968 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 — 7.75 Inch FDA UDI
Category: Orthopaedic osteotome handle
Schrom 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 de14e399-4c87-4a0e-87e7-e05e37b68627 36 fields · synced May 30, 2026