Duns Number:146920025
Device Description: The Sonalis-NG Cradle is device which is used to hold an ultrasound rectal probe during pr The Sonalis-NG Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Sonalis-NG Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
Catalog Number
-
Brand Name
Cradle, Sonalis-NG
Version/Model Number
210509
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K973786
Product Code
IWJ
Product Code Name
System, Applicator, Radionuclide, Manual
Public Device Record Key
028a77f5-db7c-4481-87e3-cf90b03627ba
Public Version Date
September 24, 2018
Public Version Number
1
DI Record Publish Date
August 23, 2018
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |