Catalog Number

-

Brand Name

Clear Blue

Version/Model Number

Digi 2.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K172426

Product Code

EBZ

Product Code Name

Activator, Ultraviolet, For Polymerization

Public Device Record Key

7f03ffe5-8942-4efa-9947-6968213dd05f

Public Version Date

February 28, 2022

Public Version Number

3

DI Record Publish Date

August 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-