Duns Number:131489882
Device Description: TR BAND Radial Artery Compression Device
Catalog Number
TRB29-LRG
Brand Name
TR BAND
Version/Model Number
TRB29-LRG
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152525,K152525,K152525
Product Code
DXC
Product Code Name
CLAMP, VASCULAR
Public Device Record Key
4209f21f-d046-4f81-870f-ac14150cf0d4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50389701011351
Quantity per Package
20
Contains DI Package
30389701011357
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |
| 3 | A medical device with high risk that requires premarket approval | 4 |