Catalog Number

-

Brand Name

Low Speed Handpiece Sleeve

Version/Model Number

670450

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151123,K151123

Product Code

PEM

Product Code Name

Dental Barriers And Sleeves

Public Device Record Key

93de25e6-cd83-48ed-ac2b-c2d426217c7d

Public Version Date

October 05, 2022

Public Version Number

5

DI Record Publish Date

October 27, 2017

Package DI Number

20302736704509

Quantity per Package

500

Contains DI Package

10302736704502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box