Catalog Number

TDVS004

Brand Name

Tridyne™ Vascular Sealant

Version/Model Number

TDVS004

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

Product Code

NBE

Product Code Name

Sealant,polymerizing

Public Device Record Key

5d81d919-c4a7-4937-8ba8-9fad157e6221

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

October 31, 2018

Package DI Number

10801741099363

Quantity per Package

4

Contains DI Package

00801741099366

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA