Catalog Number

-

Brand Name

Richard-Allan® Regular Pen

Version/Model Number

2551

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)

-

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

b48919ba-a146-46b9-9f5c-c050e0b13498

Public Version Date

March 05, 2021

Public Version Number

1

DI Record Publish Date

February 25, 2021

Package DI Number

00840113222612

Quantity per Package

50

Contains DI Package

00840113222605

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-