Identity
- Trade Name
- Buxton BioMedical FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- Dahmen Osteotome, str, 20 mm FDA UDI
- Model / Reference
- 77-1120 FDA UDI
- Description
- Dahmen Osteotome, str, 20 mm FDA UDI
Identifiers
- Catalog Number
- 77-1120 FDA UDI
- Primary DI / UDI-DI
- B76877152000 FDA UDI
- FDA Product Code
- HWM FDA UDI
- GMDN Term
- Orthopaedic osteotome 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Buxton BioMedical by Buxton Biomedical, 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
- Buxton Biomedical, Inc.
Sources (1)
- FDA UDI e18fed5e-9338-4107-b51a-d20213a20d34 35 fields · synced May 30, 2026