Catalog Number

-

Brand Name

Premium Plus International Limited

Version/Model Number

C01-S

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

531c08d7-59fe-4476-9bab-e238e7e3f315

Public Version Date

January 02, 2020

Public Version Number

1

DI Record Publish Date

December 25, 2019

Package DI Number

D838C01S8

Quantity per Package

10

Contains DI Package

D838C01S2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case