Catalog Number

-

Brand Name

PHOENIX DIAGNOSTICS, INC.

Version/Model Number

16-217

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JCB

Product Code Name

Detergent

Public Device Record Key

05e898b7-589c-49fd-9e89-b1ff2019a36d

Public Version Date

March 30, 2020

Public Version Number

3

DI Record Publish Date

January 26, 2018

Package DI Number

10853366007230

Quantity per Package

14

Contains DI Package

00853366007233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case