Duns Number:828557293
Catalog Number
T5-3035-151-US
Brand Name
Tryton Side Branch Stent
Version/Model Number
T5-3035-151-US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Product Code
MAF
Product Code Name
Stent, Coronary
Public Device Record Key
a2caaf13-48d4-4ce6-8ed0-75eb547e3a44
Public Version Date
January 06, 2020
Public Version Number
5
DI Record Publish Date
March 02, 2017
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 |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 7 |