Duns Number:078572603
Device Description: 1” x 18” Tourniquet, Textured, Latex Free, Pink
Catalog Number
-
Brand Name
HCS
Version/Model Number
HCS500P
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
56f77d05-d188-4593-b4fd-78cf22750259
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
February 28, 2020
Package DI Number
10849027000719
Quantity per Package
4
Contains DI Package
00849027000712
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 | 72 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |