Catalog Number

-

Brand Name

SOLEIL

Version/Model Number

5128-185

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

697fc523-cf96-4c66-956c-84cce6a3ea1c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 02, 2017

Package DI Number

D74451281851

Quantity per Package

100

Contains DI Package

D74451281850

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE