Duns Number:002348191
Device Description: MATRESPONDER TOURNIQUET
Catalog Number
MATR
Brand Name
ARROW
Version/Model Number
IPN038256
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"
Yes
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
1f9177f2-3ac5-4b21-bdd9-a4b4dab95eac
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 15, 2018
Package DI Number
34026704628729
Quantity per Package
100
Contains DI Package
14026704628725
Package Discontinue Date
April 01, 2021
Package Status
Not in Commercial Distribution
Package Type
Multipack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3195 |
2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
3 | A medical device with high risk that requires premarket approval | 3 |
U | Unclassified | 26 |