Catalog Number

-

Brand Name

Skin MarkOR Fine Tip

Version/Model Number

SMOR-F

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

FZZ

Product Code Name

Marker, Skin

Public Device Record Key

5fbb8aed-19f1-4abd-8107-0dfcfd92279f

Public Version Date

April 20, 2021

Public Version Number

1

DI Record Publish Date

April 12, 2021

Package DI Number

09349967004043

Quantity per Package

36

Contains DI Package

09349967004036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser Box