Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

N800-BLUE

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

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

NRD

Product Code Name

Unit, Operative Dental, Accessories

Public Device Record Key

c37f82c0-0bf7-496f-a00a-cfee5da75d2c

Public Version Date

January 15, 2020

Public Version Number

1

DI Record Publish Date

January 07, 2020

Package DI Number

D838N800BLUE8

Quantity per Package

10

Contains DI Package

D838N800BLUE6

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE