Catalog Number

-

Brand Name

Biotronix Healthcare Syringes

Version/Model Number

GE12022

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 30, 2029

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)

Yes

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

c3f79cca-4086-4eab-a4b9-1aff8fff2228

Public Version Date

December 24, 2019

Public Version Number

2

DI Record Publish Date

September 29, 2019

Package DI Number

10858835007308

Quantity per Package

100

Contains DI Package

00858835007301

Package Discontinue Date

August 31, 2028

Package Status

In Commercial Distribution

Package Type

INNER BOX