Duns Number:041674552
Device Description: 1"x18" Light Blue Rolled Tourniquet
Catalog Number
Not Applicable
Brand Name
MedSource Tourniquet
Version/Model Number
MS-17315
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
e170a13f-a39b-4825-89aa-55a57bb79767
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
May 10, 2021
Package DI Number
00840155412491
Quantity per Package
100
Contains DI Package
00816703025376
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 | 498 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |