Catalog Number

271576

Brand Name

TUMARK Flex

Version/Model Number

271576

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2018

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

4bab9539-42b3-4ca5-8db6-21ad9efd7b9c

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

November 03, 2015

Package DI Number

04250195604682

Quantity per Package

5

Contains DI Package

04250195602213

Package Discontinue Date

November 30, 2018

Package Status

Not in Commercial Distribution

Package Type

-