Catalog Number

-

Brand Name

Premium Plus International Limited

Version/Model Number

C01

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EBZ

Product Code Name

Activator, Ultraviolet, For Polymerization

Public Device Record Key

953574b1-8128-4cbe-828d-019b66e37f09

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 19, 2016

Package DI Number

D838C018

Quantity per Package

10

Contains DI Package

D838C012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box