Duns Number:118492643
Device Description: The device is intended for use in controlling compressible hemorrhage in areas not amendab The device is intended for use in controlling compressible hemorrhage in areas not amendable to limb tourniquets and providing hands-free compression on top of a packed wound when attached to the TMT Tourniquet.
Catalog Number
31-150
Brand Name
TQ™ RAM
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 02, 9999
Issuing Agency
In HIBCC
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)
Yes
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
971d5434-f95c-43b1-aa1f-2f58f063e1e4
Public Version Date
June 13, 2022
Public Version Number
1
DI Record Publish Date
June 03, 2022
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |