Biotronik Fortress 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.

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More Product Details

Catalog Number

444481

Brand Name

Biotronik Fortress Introducer Sheath System

Version/Model Number

90 cm, 6F Straight

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

K153197,K153197

Product Code Details

Product Code

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

26bcbf60-2ea9-4875-8df3-383ee54e266a

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

November 30, 2018

Additional Identifiers

Package DI Number

14251244500600

Quantity per Package

5

Contains DI Package

04251244500603

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Packer

"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