Duns Number:068586441
Device Description: Tourniquet LF 1" x 18" Blue 250/Bx
Catalog Number
782039
Brand Name
Dealmed
Version/Model Number
782039
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
-
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
5a0a2b1d-475a-46a7-977a-d7116f424074
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 19, 2021
Package DI Number
00817415020765
Quantity per Package
10
Contains DI Package
00817415020604
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 37 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |