4ch Flex SPEEDER - 4ch Flex SPEEDER - CANON MEDICAL SYSTEMS CORPORATION

Duns Number:690575113

Device Description: 4ch Flex SPEEDER

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


More Product Details

Catalog Number

-

Brand Name

4ch Flex SPEEDER

Version/Model Number

MJAJ-192A

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

K112366

Product Code Details

Product Code

MOS

Product Code Name

Coil, magnetic resonance, specialty

Device Record Status

Public Device Record Key

71b63fff-49be-4433-b270-80bd5cd85dfb

Public Version Date

March 05, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CANON MEDICAL SYSTEMS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 200