Catalog Number

-

Brand Name

FOLLISTIM PEN STARTER KIT SAM USA

Version/Model Number

1746811

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

NSC

Product Code Name

INJECTOR, PEN

Public Device Record Key

25bbf343-06a1-4a7b-8c56-9fd255750032

Public Version Date

November 05, 2019

Public Version Number

1

DI Record Publish Date

October 28, 2019

Package DI Number

60300520311535

Quantity per Package

12

Contains DI Package

00300520311533

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box