Duns Number:290318455
Device Description: The product concerned is a plastic guide designed to be plugged on an endocavity ultrasoun The product concerned is a plastic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument through transrectal access. The guide is composed of 2 parts welded together to have:• a channel to receive and guide the linear instrument • a clip to allow the guide stability on the transducer • 2 pins for attachment in the notches of the probe• a guide cone to introduce easily the needle into the tube
Catalog Number
KDNG-XX
Brand Name
Disposable guide for 3D endocavity end-fire
Version/Model Number
KDNG00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 08, 2022
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
Yes
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
K180970,K180970,K180970
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
79218aab-3004-4a3c-8afe-026186bd515b
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
July 20, 2018
Package DI Number
03665134000028
Quantity per Package
4
Contains DI Package
03665134000011
Package Discontinue Date
April 08, 2022
Package Status
Not in Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |