Catalog Number

TSIL08563

Brand Name

Transseptal Introducer

Version/Model Number

TSIL08563

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

K181031,K181031

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

43dac2c5-9a9c-4a8a-be90-e35c543efd85

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

November 09, 2018

Package DI Number

30858769006310

Quantity per Package

5

Contains DI Package

00858769006319

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box