Catalog Number

978383

Brand Name

True™ Dental Dam Latex 6x6 Sample Pack

Version/Model Number

978383

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EIE

Product Code Name

DAM, RUBBER

Public Device Record Key

70b74995-6b5d-4f5c-ba91-cb5db8cd6b55

Public Version Date

April 27, 2022

Public Version Number

1

DI Record Publish Date

April 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-