Catalog Number

-

Brand Name

Philips Zoom

Version/Model Number

DIS203/30

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

IWS

Product Code Name

Shield, eye, radiological

Public Device Record Key

a81e47a0-60f2-4121-8fa4-6dae81113144

Public Version Date

September 28, 2020

Public Version Number

1

DI Record Publish Date

September 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-