Duns Number:131480662
Device Description: The Tramedic® Trauma Bandage is a simple, effective pressure dressing designed to treat no The Tramedic® Trauma Bandage is a simple, effective pressure dressing designed to treat non-life threatening hemorrhaging. It utilizes an elastic wrap material that can be used to generate pressure and a sterile wound pad that can be placed directly over the injury to aid the control of bleeding. The bandage is flat folded and vacuum-sealed to create a low profile so it can be easily stored.
Catalog Number
TR011
Brand Name
TRAMEDIC® TRAUMA BANDAGE
Version/Model Number
A
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"
-
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
MHW
Product Code Name
Dressing, Compression
Public Device Record Key
215c4aa3-506e-421c-8beb-0f554b04e4ee
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
October 15, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |