Duns Number:004163390
Device Description: Hysynal Synthetic Rubber Tourniquet Strap, Perforated
Catalog Number
-
Brand Name
Hysynal
Version/Model Number
10204
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)
-
Over the Counter (OTC)
Yes
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
74ddd5ac-c506-4d77-ba14-f24355234fda
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
April 08, 2019
Package DI Number
30087453102049
Quantity per Package
10
Contains DI Package
10087453102045
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |