Catalog Number

CTK-6

Brand Name

Symphony Centesis Drainage Kit

Version/Model Number

CTK-6

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 16, 2020

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"

Yes

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

-

Product Code

KGZ

Product Code Name

Accessories, Catheter

Public Device Record Key

1b5efe70-725e-41f4-b586-adbacd56accd

Public Version Date

January 17, 2020

Public Version Number

3

DI Record Publish Date

September 11, 2017

Package DI Number

20817640020022

Quantity per Package

8

Contains DI Package

00817640020028

Package Discontinue Date

January 16, 2020

Package Status

Not in Commercial Distribution

Package Type

SHIPPER