Catalog Number

TCK-2002

Brand Name

Inion GTR™

Version/Model Number

1

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

K033074

Product Code

NPK

Product Code Name

Barrier, synthetic, intraoral

Public Device Record Key

9515a4b0-bb20-408a-a3c8-44f7a928390f

Public Version Date

October 21, 2020

Public Version Number

5

DI Record Publish Date

February 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-