Identity
- Trade Name
- Buxton Biomedical FDA UDI
- Generic Name
- Surgical gouge FDA UDI
- Device Name
- Mini-Lexer Gouge, 5 mm wide FDA UDI
- Model / Reference
- 56-7605 FDA UDI
- Description
- Mini-Lexer Gouge, 5 mm wide FDA UDI
Identifiers
- Catalog Number
- 56-7605 FDA UDI
- Primary DI / UDI-DI
- B7685676050 FDA UDI
- FDA Product Code
- GDH FDA UDI
- GMDN Term
- Surgical gouge 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
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
Microwave Radiation FDA UDI
Category: Surgical gouge
Buxton Biomedical by Buxton Biomedical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical gouge.
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- Sklar® — Sklar Corporation · Class I
- Sklar® — Sklar Corporation · Class I
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 82d1ac04-9bac-4330-b54b-6952ce1346d9 34 fields · synced May 30, 2026