Catalog Number

TN004

Brand Name

Composi-Tight®

Version/Model Number

TN004

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

-

Product Code

EIY

Product Code Name

Instrument, Filling, Plastic, Dental

Public Device Record Key

ce2a339c-2167-4a96-83f3-7265a991cdb6

Public Version Date

September 22, 2020

Public Version Number

2

DI Record Publish Date

April 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-