Catalog Number

838200

Brand Name

True™ Dental Dam Latex Free 5x5

Version/Model Number

838200

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

3c56bd8e-e1f7-4673-b2bb-e1a3fcd7bd78

Public Version Date

November 06, 2020

Public Version Number

1

DI Record Publish Date

October 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-