Catalog Number

1127093

Brand Name

Henry Schein

Version/Model Number

1127093

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)

Yes

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

973813ca-ab79-4a7f-9e1a-51d64acd0264

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10304040005023

Quantity per Package

5

Contains DI Package

00304040005026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-