Catalog Number

1004568

Brand Name

Henry Schein

Version/Model Number

1004568

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

EHZ

Product Code Name

Evacuator, oral cavity

Public Device Record Key

b63e73e1-7e13-4f5e-886e-99d70b380757

Public Version Date

February 11, 2019

Public Version Number

1

DI Record Publish Date

January 11, 2019

Package DI Number

20304040039919

Quantity per Package

20

Contains DI Package

10304040039912

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case