Catalog Number

-

Brand Name

Praxis Medical CytoCore and CytoCore Luer Adapters

Version/Model Number

C0025L

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

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

f3894c8f-3c20-438a-83fd-b287f5b2ded0

Public Version Date

June 15, 2022

Public Version Number

1

DI Record Publish Date

June 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-