Duns Number:392994778
Device Description: Standard VENE K - Single use tourniquet
Catalog Number
00580501
Brand Name
VYGON
Version/Model Number
5805.01
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
-
Product Code
GAX
Product Code Name
TOURNIQUET, NONPNEUMATIC
Public Device Record Key
40297dbc-8ba0-4742-b14d-3097aa637344
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 09, 2021
Package DI Number
33660812124882
Quantity per Package
100
Contains DI Package
03660812124881
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |