Catalog Number

GE36412

Brand Name

Biotronix Healthcare

Version/Model Number

GE36412

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

K050999,K050999,K050999

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

8eb3a264-f9dd-4dee-9e53-7ef9dc7e076b

Public Version Date

December 24, 2019

Public Version Number

3

DI Record Publish Date

October 06, 2019

Package DI Number

20858835007046

Quantity per Package

100

Contains DI Package

10858835007049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case