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VERSAJET III PRECISION Hydrosurgery System Hand Piece
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- VERSAJET III PRECISION Hydrosurgery System Hand Piece FDA UDI
- Generic Name
- Water jet knife system handpiece, single-use FDA UDI
- Device Name
- VERSAJET III PRECISION HANDPIECE 45DEGx8MM FDA UDI
- Model / Reference
- 66802149 FDA UDI
- Description
- VERSAJET III PRECISION HANDPIECE 45DEGx8MM FDA UDI
Identifiers
- Catalog Number
- 66802149 FDA UDI
- Primary DI / UDI-DI
- 05000223498153 FDA UDI
- 510(k) Number
- K220964 FDA UDI
- FDA Product Code
- FQH FDA UDI
- GMDN Term
- Water jet knife system handpiece, single-use 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Angle — 45 degree FDA UDI
Category: Water jet knife system handpiece, single-use
VERSAJET III PRECISION Hydrosurgery System Hand Piece by Smith & Nephew Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Water jet knife system handpiece, single-use.
- SpineJet® — HYDROCISION, INC. · Class II
- SpineJet® — HYDROCISION, INC. · Class II
- SpineJet® — HYDROCISION, INC. · Class II
- SpineJet® — HYDROCISION, INC. · Class II
- SpineJet® — HYDROCISION, INC. · Class II
- SpineJet® — HYDROCISION, INC. · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- SpineJet® — HYDROCISION, INC. · Class II
Cleared under the same submission
K220964 also covers:
- VERSAJET III Hydrosurgery System Console — Smith & Nephew Medical, Ltd.
- VERSAJET III Hydrosurgery System Foot Pedal — Smith & Nephew Medical, Ltd.
- VERSAJET III PRECISION Hydrosurgery System Hand Piece — Smith & Nephew Medical, Ltd.
- VERSAJET III PRECISION Hydrosurgery System Hand Piece — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew Medical, Ltd.
Sources (1)
- FDA UDI c3e50aa3-799e-47ab-95cc-df2b114c49a7 37 fields · synced May 30, 2026