Catalog Number

1047423

Brand Name

Henry Schein

Version/Model Number

1047423

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

08ec3a83-3d6b-49d0-bd7e-7d9f9770b6ec

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

20304040035737

Quantity per Package

36

Contains DI Package

10304040035730

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-