Duns Number:007941230
Device Description: Tourniquet Textured Orange Premium Bulk Bag 1 X 18 Inch Polyisoprene Not Made With Natural Tourniquet Textured Orange Premium Bulk Bag 1 X 18 Inch Polyisoprene Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
TRN1182
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)
-
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
d0cf1188-924e-4f4e-8302-fa4ac097efbe
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 21, 2020
Package DI Number
50885632127210
Quantity per Package
4
Contains DI Package
30885632127216
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |