Catalog Number

DGK002X

Brand Name

Galactography Kit

Version/Model Number

DGK002X

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"

-

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

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

83430563-73d3-48de-b72f-b4ff247494e3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 12, 2016

Package DI Number

20886333001587

Quantity per Package

10

Contains DI Package

00886333001583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box