Identity
- Trade Name
- Handpiece FDA UDI
- Generic Name
- Ultrasonic surgical system generator FDA UDI
- Device Name
- Handpiece BoneWelder 150-W1 FDA UDI
- Model / Reference
- Handpiece FDA UDI
- Description
- Handpiece BoneWelder 150-W1 FDA UDI
Identifiers
- Catalog Number
- H04-001 FDA UDI
- Primary DI / UDI-DI
- 07649990202143 FDA UDI
- 510(k) Number
- K171228 FDA UDI
- FDA Product Code
- GAT FDA UDIMAI FDA UDIHTY FDA UDI
- GMDN Term
- Ultrasonic surgical system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 FDA UDI888.3030 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
Moist Heat or Steam Sterilization FDA UDI
Handpiece 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 0f28b951-5031-4737-82a4-c944af517a55 37 fields · synced Jun 1, 2026