Catalog Number

-

Brand Name

GearView QC

Version/Model Number

3X

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

K083618,K083618,K083618

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

a3b0b1ee-fabc-486f-8a70-203f57f240ea

Public Version Date

December 09, 2020

Public Version Number

2

DI Record Publish Date

September 30, 2020

Package DI Number

00850677007334

Quantity per Package

1

Contains DI Package

00850677007327

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-