Catalog Number

271500

Brand Name

TUMARK Q

Version/Model Number

271500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

dd6c0b3d-1991-40b7-ae22-028f78bc307a

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 30, 2015

Package DI Number

04250195604613

Quantity per Package

10

Contains DI Package

04250195603081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-