Duns Number:023904428
Device Description: BANDAGE, ESMARK LF STR 4"X12'(20/CS)
Catalog Number
-
Brand Name
Cypress
Version/Model Number
16-50412
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
47ec936f-e32e-4787-bc06-816c7db9bed4
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
May 22, 2020
Package DI Number
40612479179910
Quantity per Package
20
Contains DI Package
20612479179909
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |