Catalog Number

-

Brand Name

Tumark Eye

Version/Model Number

271512

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

c1d225fb-b5d0-457f-b6d8-9baf5ecf0d04

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

December 19, 2017

Package DI Number

04250195611376

Quantity per Package

10

Contains DI Package

04250195611369

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-