Duns Number:146920025
Device Description: The Sonalis Cradle is device which is used to hold an ultrasound rectal probe during prost The Sonalis Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Sonalis 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
Version/Model Number
210222
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
a87018a0-061a-4248-bd2e-0f24823f9a51
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 31, 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 |
|---|---|---|
| 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 |