Catalog Number

351252

Brand Name

TUMARK Flex

Version/Model Number

351252

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

b36a2dd3-e202-40c1-b2ca-89031afbbff5

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

February 17, 2017

Package DI Number

14250195611212

Quantity per Package

5

Contains DI Package

04250195611215

Package Discontinue Date

July 30, 2020

Package Status

Not in Commercial Distribution

Package Type

-