Identity
- Trade Name
- BoneWelder 150-W1 FDA UDI
- Generic Name
- Ultrasonic surgical system generator FDA UDI
- Model / Reference
- BoneWelder 150-W1 FDA UDI
Identifiers
- Catalog Number
- BW04-001 FDA UDI
- Primary DI / UDI-DI
- 07649990202150 FDA UDI
- 510(k) Number
- K171228 FDA UDI
- FDA Product Code
- MAI FDA UDIGAT FDA UDIHTY FDA UDI
- GMDN Term
- Ultrasonic surgical system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI878.5000 FDA UDI888.3040 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
BoneWelder 150-W1 by Surgical Fusion Technologies GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Surgical Fusion Technologies GmbH
Sources (1)
- FDA UDI 97fa1e63-cc20-4369-8cd3-ba75d9d2a4f0 37 fields · synced Jun 1, 2026