Catalog Number

-

Brand Name

GBUK

Version/Model Number

1

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"

Yes

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

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

e8edea6b-e888-4647-b62e-69262991d4fa

Public Version Date

May 28, 2021

Public Version Number

1

DI Record Publish Date

May 20, 2021

Package DI Number

16971911299160

Quantity per Package

100

Contains DI Package

06971911299163

Package Discontinue Date

May 13, 2021

Package Status

Not in Commercial Distribution

Package Type

box