Catalog Number

-

Brand Name

ClarifEye Marker

Version/Model Number

45980159392x

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"

-

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

FZZ

Product Code Name

Marker, Skin

Public Device Record Key

33694bc7-e938-406c-a53c-6efc2861b5bf

Public Version Date

July 30, 2021

Public Version Number

1

DI Record Publish Date

July 22, 2021

Package DI Number

00884838097568

Quantity per Package

20

Contains DI Package

00884838096844

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-