Duns Number:544914187
Catalog Number
-
Brand Name
Phased array probe
Version/Model Number
P5-V
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K170374,K170374,K170374
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
a7c9b2ca-0dc3-4aac-8ad2-867625ab1c24
Public Version Date
September 05, 2022
Public Version Number
6
DI Record Publish Date
June 16, 2017
Package DI Number
06945121411707
Quantity per Package
1
Contains DI Package
06945121411431
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 94 |