Duns Number:014438860
Device Description: Diagnostic Ultrasound Transducer
Catalog Number
51414
Brand Name
UHF22 Transducer
Version/Model Number
51414-30
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
K160674
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
9ab7638a-62af-43c3-af0d-75798f065b4f
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
July 21, 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. | 690 |