Catalog Number

613735BU

Brand Name

Bluephase 20i

Version/Model Number

613735BU

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 28, 2021

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

78415784-75b0-4f90-a128-15ddf925e724

Public Version Date

February 04, 2021

Public Version Number

1

DI Record Publish Date

January 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-