Catalog Number

Tumark-E13-P-Vision

Brand Name

Tumark® Vision for Eviva® Petite

Version/Model Number

Tumark-E13-P-Vision

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

4ba8aa66-8ace-4841-8104-734ba54ea89a

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 26, 2018

Package DI Number

24250195611233

Quantity per Package

10

Contains DI Package

14250195611236

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-