Catalog Number

31G-END

Brand Name

GALACTOGRAPHY STRAIGHT INFUSION, 31 GA

Version/Model Number

31 Gauge

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

GCB

Product Code Name

Needle, Catheter

Public Device Record Key

68d95b2f-bb6a-4339-b23b-2e077d1c70ce

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 09, 2017

Package DI Number

M9796800807M9

Quantity per Package

22

Contains DI Package

M9796800807M1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case