Catalog Number

PCI 40-1005

Brand Name

Phoenix Clinical White Light Module

Version/Model Number

PCI 40-1005

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

-

Product Code

PJZ

Product Code Name

Camera, Ophthalmic, General-Use

Public Device Record Key

b2e2d56e-8b0b-417e-877f-9797ded7e01e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 18, 2016

Package DI Number

00857253006095

Quantity per Package

1

Contains DI Package

00857253006064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box