TOTOKU - JVC KENWOOD CORPORATION

Duns Number:713321040

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

TOTOKU

Version/Model Number

CCL550i2/F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K160326

Product Code Details

Product Code

PGY

Product Code Name

Display, Diagnostic Radiology

Device Record Status

Public Device Record Key

ba427c0b-efff-4718-b7a2-e729eb0f1652

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JVC KENWOOD CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 56