Catalog Number

BS-N1A2713U6

Brand Name

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

Version/Model Number

BS-N1A2713U6

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 19, 2018

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

0af10f76-2e8b-42fa-9d57-da5b8805320b

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

March 15, 2017

Package DI Number

55413206214162

Quantity per Package

120

Contains DI Package

35413206214168

Package Discontinue Date

June 19, 2018

Package Status

Not in Commercial Distribution

Package Type

Carton