Catalog Number

6200-0200

Brand Name

GPS Pusher

Version/Model Number

6200-0200

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

-

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

K170306

Product Code

KIH

Product Code Name

Dispenser, Cement

Public Device Record Key

71166a5a-9514-4ac2-b9c9-0cee1089cd3e

Public Version Date

January 04, 2019

Public Version Number

5

DI Record Publish Date

December 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-