Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

9903B

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

EJB

Product Code Name

Handle, Instrument, Dental

Public Device Record Key

7348e66b-2af8-4db5-87f1-990c2a8c4b6a

Public Version Date

January 13, 2020

Public Version Number

1

DI Record Publish Date

January 03, 2020

Package DI Number

D8389903B8

Quantity per Package

20

Contains DI Package

D8389903B2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case