Catalog Number

2100ML7

Brand Name

ML7 Eye Marker

Version/Model Number

2100ML7

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

-

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

HMR

Product Code Name

Marker, Ocular

Public Device Record Key

e2d5fe19-35db-497f-8c56-978e1c2a8473

Public Version Date

September 07, 2020

Public Version Number

1

DI Record Publish Date

August 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-