Catalog Number

-

Brand Name

FOLLISTIM AQ Cartridge 900IU

Version/Model Number

1022679

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

e115c7be-4c99-41d1-9f41-a1c24c883b2b

Public Version Date

November 22, 2019

Public Version Number

1

DI Record Publish Date

November 14, 2019

Package DI Number

60300520326010

Quantity per Package

24

Contains DI Package

00300520326018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box