Catalog Number

295682

Brand Name

Young

Version/Model Number

295682

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

211c67bd-c819-4e06-92f1-631a74ad1018

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 16, 2022

Package DI Number

10302732956820

Quantity per Package

125

Contains DI Package

00302732956823

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box