Catalog Number

TDST0020

Brand Name

Tridyne™ Vascular Sealant Standard Spray Tips

Version/Model Number

TDST0020

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

Yes

FDA Premarket Submission

P150016,P150016,P150016

Product Code

NBE

Product Code Name

Sealant,polymerizing

Public Device Record Key

d580f863-ac42-4d95-b5ae-4d008511af43

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

October 31, 2018

Package DI Number

20801741099377

Quantity per Package

10

Contains DI Package

10801741099370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA