Catalog Number

838203

Brand Name

True™ Dental Dam Latex Free 6x6 Heavy Gauge

Version/Model Number

838203

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)

-

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

87b87576-3c87-4c60-911b-e2a7ce4e7d7f

Public Version Date

April 11, 2022

Public Version Number

1

DI Record Publish Date

April 02, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-