Duns Number:939493362
Device Description: The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft ti
Catalog Number
-
Brand Name
Praxis Medical
Version/Model Number
C0025
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
K200278,K200278,K200278
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
63760b3f-0343-485f-a9fd-1445af7df8dd
Public Version Date
August 17, 2020
Public Version Number
1
DI Record Publish Date
August 07, 2020
Package DI Number
00860003935811
Quantity per Package
5
Contains DI Package
00860003935804
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-