Duns Number:019677418
Device Description: PA7-4/12, Phased Array Transducer
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
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
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 43 |