Catalog Number

1126239

Brand Name

Henry Schein

Version/Model Number

1126239

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EGS

Product Code Name

Handpiece, contra- and right-angle attachment, dental

Public Device Record Key

5611beb6-6ee3-48c1-b38f-54f425d6d6c8

Public Version Date

June 25, 2020

Public Version Number

1

DI Record Publish Date

June 17, 2020

Package DI Number

H65811262392

Quantity per Package

4

Contains DI Package

H65811262391

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-