Duns Number:014438860
Device Description: Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x u Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultrasound transducer.
Catalog Number
P20810
Brand Name
AxoTrack I Sterile Procedure Kit
Version/Model Number
P20810-03
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
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
K113680
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
ce6c7cb7-e4ed-4a0b-9976-f9fd3e140d51
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 05, 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. | 690 |