Catalog Number

428033

Brand Name

Advance Dental Products

Version/Model Number

428033

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PEM

Product Code Name

Dental barriers and sleeves

Public Device Record Key

564f81a4-7534-4578-bf87-6457d1869fa1

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Package DI Number

20850455007499

Quantity per Package

6

Contains DI Package

10850455007492

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE