Catalog Number

5702462

Brand Name

Henry Schein

Version/Model Number

5702462

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

K030603,K030603,K030603

Product Code

EGS

Product Code Name

Handpiece, contra- and right-angle attachment, dental

Public Device Record Key

33b6e493-45da-4a39-8294-b92cb7d432dd

Public Version Date

April 01, 2021

Public Version Number

1

DI Record Publish Date

March 24, 2021

Package DI Number

20304040142671

Quantity per Package

12

Contains DI Package

10304040142674

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case