Duns Number:600054688
Device Description: The CW 8MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic signals a The CW 8MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and intended to be used in combination with the RIMED's Transcranial Doppler System.
Catalog Number
23-635
Brand Name
CW 8MHz Ultrasonic Probe
Version/Model Number
CW 8MHz Ultrasonic Probe
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
K062578
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
9bddefaf-b73b-4c26-a0e3-67854858cf8d
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
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. | 7 |