Catalog Number

351250

Brand Name

TUMARK Flex

Version/Model Number

351250

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2020

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

2d95e4d4-2d2a-419d-b6a2-dbb87464269d

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

February 17, 2017

Package DI Number

14250195611205

Quantity per Package

5

Contains DI Package

04250195611208

Package Discontinue Date

July 30, 2020

Package Status

Not in Commercial Distribution

Package Type

-