Catalog Number

TL-19S

Brand Name

TLAB Transjugular Liver Biopsy System

Version/Model Number

TL-19S

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

-

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

9c212ca6-f0e2-4685-8849-85a18b9823e8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Package DI Number

20886333218541

Quantity per Package

5

Contains DI Package

00886333218547

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box