Catalog Number

30G-END

Brand Name

SIALOGRAPHY UNIT ENDPORT, 30GA

Version/Model Number

30 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

b727e2aa-0ac1-40bb-bcd3-d6452da3676a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 09, 2017

Package DI Number

M9796800803M9

Quantity per Package

22

Contains DI Package

M9796800803M1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case