Catalog Number

-

Brand Name

Setmark Incorporated

Version/Model Number

TR-135

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

-

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

ITJ

Product Code Name

Walker, Mechanical

Public Device Record Key

530e26d3-ed9e-468e-b8e9-065a8ccc11dd

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

January 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-