Ultrasonix Medical Corporation - PA7-4/12, Phased Array Transducer - ANALOGIC CORPORATION

Duns Number:019677418

Device Description: PA7-4/12, Phased Array Transducer

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More Product Details

Catalog Number

-

Brand Name

Ultrasonix Medical Corporation

Version/Model Number

00.035.072

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

2c6f0520-c819-4e45-83fb-1ba0ae9b2c9f

Public Version Date

January 28, 2020

Public Version Number

4

DI Record Publish Date

November 17, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANALOGIC CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 43