TLAB Transjugular Liver Biopsy System - TLAB Transjugular Liver Biopsy System - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: TLAB Transjugular Liver Biopsy System

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More Product Details

Catalog Number

TL-19N

Brand Name

TLAB Transjugular Liver Biopsy System

Version/Model Number

TL-19N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

fcb114e2-d7ce-4db6-bc36-bba552dd0ca3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

20886333218558

Quantity per Package

5

Contains DI Package

00886333218554

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205