Catalog Number

GE36403

Brand Name

Biotronix Healthcare Hypodermic Needles

Version/Model Number

GE36403

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

caecab43-733f-4181-92e1-d69ee435d9f7

Public Version Date

December 24, 2019

Public Version Number

3

DI Record Publish Date

October 06, 2019

Package DI Number

20858835007978

Quantity per Package

20

Contains DI Package

10858835007971

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case