Catalog Number

09000

Brand Name

triton

Version/Model Number

09000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

October 04, 2099

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

-

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

IYB

Product Code Name

Tube Mount, X-Ray, Diagnostic

Public Device Record Key

cdd23edb-02a5-45a4-845d-ece3f2f3cb19

Public Version Date

August 09, 2021

Public Version Number

4

DI Record Publish Date

November 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-