FDA UDI
In Commercial Distribution
🇺🇸 United States
VERSAJET III PRECISION Hydrosurgery System Hand Piece
DI: 05000223498139
·
Model: 66802148
·
SMITH & NEPHEW MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VERSAJET III PRECISION Hydrosurgery System Hand Piece
- Primary DI
- 05000223498139
- Version / Model
- 66802148
- Catalog Number
- 66802148
- Company Name
- SMITH & NEPHEW MEDICAL LIMITED
- Labeler DUNS
- 216344051
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-31
- Public Version
- 2
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 68fad0c7-acc5-4b2a-96b1-99af1a4122d7
Device Description
VERSAJET III PRECISION HANDPIECE 45DEGx14MM
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQH | Lavage, Jet | General Hospital | 880.5475 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47559 | Water jet knife system handpiece, single-use | A sterile, hand-operated device that is a component of a water jet knife system and designed to direct a concentrated stream of high-pressure water (typically sterile saline) to a surgical site to cut/dissect tissue. This handpiece is connected to a generator that pressurizes the water; it may also facilitate the aspiration of fluid and debris from the surgical site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05000223498146 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 05000223498139 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220964 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 45 | degree | |
| Device Size Text, specify | "430x290x45 (Carton) 464x311x228 (Shipper)" |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius