Catalog Number

682110

Brand Name

Bluephase 20i

Version/Model Number

682110

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

e359ff4d-83a2-4d74-b728-40e6ef7f6e67

Public Version Date

February 10, 2022

Public Version Number

3

DI Record Publish Date

February 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-