Catalog Number

BS-N1A2713U

Brand Name

Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600IU/ml FSH

Version/Model Number

BS-N1A2713U

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

K161606,K161606,K161606

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

f59ff42c-e545-4cd6-b90e-d217ff767179

Public Version Date

September 05, 2022

Public Version Number

4

DI Record Publish Date

September 26, 2017

Package DI Number

55413206220248

Quantity per Package

18

Contains DI Package

35413206220244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton