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 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"

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

080ac03a-461b-4548-b552-d028d3c4f38f

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Package DI Number

20304040060265

Quantity per Package

4

Contains DI Package

10304040060268

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-