Identity
- Trade Name
- Versajet FDA UDI
- Generic Name
- Water jet knife system generator FDA UDI
- Device Name
- Versajet II Hydrosurgery System Console FDA UDI
- Model / Reference
- 66800039 FDA UDI
- Description
- Versajet II Hydrosurgery System Console FDA UDI
Identifiers
- Catalog Number
- 66800039 FDA UDI
- Primary DI / UDI-DI
- 00040565124759 FDA UDI
- 510(k) Number
- K143115 FDA UDI
- FDA Product Code
- FQH FDA UDI
- GMDN Term
- Water jet knife system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5475 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Water jet knife system generator
Versajet by Smith & Nephew Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143115 also covers:
- Renasys — Smith & Nephew Medical, Ltd.
- VERSAJET™ II — Smith & Nephew Medical, Ltd.
- VERSAJET™ II — Smith & Nephew Medical, Ltd.
- Versajet — Smith & Nephew Medical, Ltd.
- Versajet — Smith & Nephew Medical, Ltd.
- Versajet — Smith & Nephew Medical, Ltd.
- Versajet — Smith & Nephew Medical, Ltd.
- Versajet — Smith & Nephew Medical, Ltd.
- Versajet — Smith & Nephew Medical, Ltd.
- Versajet — Smith & Nephew Medical, Ltd.
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
- Smith & Nephew Medical, Ltd.
Sources (1)
- FDA UDI 9ca5e57b-e0be-4d7f-8042-c372f7c0502d 35 fields · synced Jun 6, 2026