Catalog Number

M004TSXNEEDLE100

Brand Name

TSX™ Transseptal Needle

Version/Model Number

00884450451717

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DRC

Product Code Name

Trocar

Public Device Record Key

d7e0debb-3721-4845-a4f4-d370c462ef96

Public Version Date

April 19, 2021

Public Version Number

3

DI Record Publish Date

October 14, 2020

Package DI Number

10884450451714

Quantity per Package

5

Contains DI Package

00884450451717

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-