Catalog Number

271549

Brand Name

TUMARK Professional X-Shape

Version/Model Number

271549

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

8595c37a-2690-4cc5-a4d4-e9e808c3cdd6

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 30, 2015

Package DI Number

04250195607096

Quantity per Package

10

Contains DI Package

04250195602282

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-