Catalog Number

GE12027

Brand Name

Biotronix Healthcare Syringes

Version/Model Number

GE12027

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

b8feb6ac-bd7c-4315-812b-e7dfcd226e4d

Public Version Date

October 17, 2022

Public Version Number

4

DI Record Publish Date

October 12, 2019

Package DI Number

20858835007350

Quantity per Package

6

Contains DI Package

10858835007353

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case