Catalog Number

20-3001

Brand Name

GPS

Version/Model Number

20-3001

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

K102254

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Public Device Record Key

a98cf416-3e67-4136-8a31-4601dca5f040

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-