Duns Number:290318455
Device Description: Probe holder for transperineal approach.The steady pro range is intended to reliably maint Probe holder for transperineal approach.The steady pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultra-sound-guided intervention.
Catalog Number
-
Brand Name
Steady Pro
Version/Model Number
KSP.SUPP.TP
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
K171040,K171040
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
cd58f1f5-c0d8-43a9-9d2b-9cd3baf064f5
Public Version Date
October 14, 2022
Public Version Number
1
DI Record Publish Date
October 06, 2022
Package DI Number
03665134000752
Quantity per Package
5
Contains DI Package
03665134000745
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. | 13 |