Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

657S-Y

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"

-

For Single-Use

-

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

NRD

Product Code Name

Unit, Operative Dental, Accessories

Public Device Record Key

e1933e92-cf42-476c-abbe-cbcfb7d7a8d8

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

January 08, 2020

Package DI Number

D838657SY8

Quantity per Package

100

Contains DI Package

D838657SY2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE