Catalog Number

271565

Brand Name

TUMARK Professional

Version/Model Number

271565

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 18, 2022

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

7f25f96f-cd67-4b8b-b02e-0ba4ba25b0f2

Public Version Date

August 19, 2022

Public Version Number

5

DI Record Publish Date

October 30, 2015

Package DI Number

04250195604644

Quantity per Package

10

Contains DI Package

04250195600820

Package Discontinue Date

August 18, 2022

Package Status

Not in Commercial Distribution

Package Type

-