Catalog Number

-

Brand Name

Barrier Sleeve, Young Infinity Cordless Handpiece, 25ct

Version/Model Number

295830

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

PEM

Product Code Name

Dental Barriers And Sleeves

Public Device Record Key

9e5bfd20-4e9e-4118-9252-0e08a592c50b

Public Version Date

October 05, 2022

Public Version Number

3

DI Record Publish Date

May 25, 2018

Package DI Number

20302732958302

Quantity per Package

400

Contains DI Package

10302732958305

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box