Catalog Number

351220

Brand Name

Tumark Professional Q-Shape

Version/Model Number

351220

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

9af36ed9-11a4-465a-8258-9dfaaaf963ae

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

February 17, 2017

Package DI Number

14250195611144

Quantity per Package

10

Contains DI Package

04250195611147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-