CW DOPPLER PENCIL TRANSDUCER - CW DOPPLER PENCIL TRANSDUCER - CANON MEDICAL SYSTEMS CORPORATION

Duns Number:690575113

Device Description: CW DOPPLER PENCIL TRANSDUCER

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More Product Details

Catalog Number

-

Brand Name

CW DOPPLER PENCIL TRANSDUCER

Version/Model Number

PC-20M

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

K151451

Product Code Details

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Device Record Status

Public Device Record Key

9e6c8d80-3968-4fda-9656-36f079cd0aed

Public Version Date

July 06, 2018

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