Catalog Number

CL-S500BG2

Brand Name

JVC

Version/Model Number

CL-S500

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

K191137

Product Code

PGY

Product Code Name

Display, Diagnostic Radiology

Public Device Record Key

fcd18a51-b309-4b34-810f-56e059dfaadf

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

January 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-