Duns Number:007941230
Device Description: Tourniquet Perforated Roll Single-patient Use Polyisoprene 1inchx18inches Blue Textured No Tourniquet Perforated Roll Single-patient Use Polyisoprene 1inchx18inches Blue Textured Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
TRN1191B
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
48738b60-3e3d-459c-938d-9c67157aee21
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 01, 2020
Package DI Number
50885632128224
Quantity per Package
40
Contains DI Package
30885632128220
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 |