Catalog Number

TSC189

Brand Name

Needle Free Transseptal Cannula

Version/Model Number

TSC189

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

K172934,K172934

Product Code

DRC

Product Code Name

Trocar

Public Device Record Key

1f44ff83-5391-4f3d-8d40-780a150234ab

Public Version Date

August 20, 2020

Public Version Number

3

DI Record Publish Date

March 02, 2018

Package DI Number

30858769006174

Quantity per Package

5

Contains DI Package

00858769006173

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box