DuraSheath Introducer Sheath System - Introducer Sheath System containing One (1) - Contract Medical International GmbH

Duns Number:330926895

Device Description: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and O Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

FG-06090

Brand Name

DuraSheath Introducer Sheath System

Version/Model Number

6F, 90cm, straigth

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

c042dd03-b4f8-4c34-a744-633eb27a80d7

Public Version Date

April 21, 2021

Public Version Number

2

DI Record Publish Date

June 30, 2019

Additional Identifiers

Package DI Number

24251244500188

Quantity per Package

1

Contains DI Package

14251244500181

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugate

"CONTRACT MEDICAL INTERNATIONAL GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 37