Catalog Number

TRI

Brand Name

Triumph Resin Dam

Version/Model Number

TRI

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EIE

Product Code Name

Dam, Rubber

Public Device Record Key

3772332d-0781-4f6d-8ace-e971dd2a4254

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 29, 2016

Package DI Number

D820TRI1

Quantity per Package

2

Contains DI Package

D820TRI0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-