Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Bone curette, reusable FDA UDI
- Device Name
- 9” Bruns Curette, Angled, Size 00000 FDA UDI
- Model / Reference
- SD9146531001 FDA UDI
- Description
- 9” Bruns Curette, Angled, Size 00000 FDA UDI
Identifiers
- Catalog Number
- SD9146531001 FDA UDI
- Primary DI / UDI-DI
- B382SD91465310010 FDA UDI
- FDA Product Code
- EMK FDA UDI
- GMDN Term
- Bone curette, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
Surgical Direct by Surgical Direct, 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
- Surgical Direct, Inc.
Sources (1)
- FDA UDI bfece54f-8950-416b-a511-75b31529f788 36 fields · synced May 31, 2026