Catalog Number

-

Brand Name

Radiance

Version/Model Number

90X0718

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 16, 2021

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

KQM

Product Code Name

Camera, Surgical And Accessories

Public Device Record Key

c930e5e1-111b-4f25-ab93-e034b065d1cd

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

December 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-