Duns Number:216344051
Device Description: Versajet II Hydrosurgery System Handset, 45deg 8mm EXACT
Catalog Number
66800042
Brand Name
Versajet
Version/Model Number
66800042
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K143115,K143115
Product Code
FQH
Product Code Name
Lavage, Jet
Public Device Record Key
16ec3404-c781-46ac-a1ae-3918f0e740e7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
30040565124699
Quantity per Package
5
Contains DI Package
00040565124698
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 126 |
| U | Unclassified | 1 |