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
MR Unsafe
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
K213531,K213531,K213531
Product Code
DXC
Product Code Name
CLAMP, VASCULAR
Public Device Record Key
62ccb587-4d7f-43ab-81c9-f9391cd4c0b4
Public Version Date
October 17, 2022
Public Version Number
1
DI Record Publish Date
October 07, 2022
Package DI Number
30389701012477
Quantity per Package
5
Contains DI Package
00389701012476
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |