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

452384

Brand Name

Biotronik Fortress Introducer Sheath System

Version/Model Number

8F, 65cm, 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

-

Product Code Details

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Device Record Status

Public Device Record Key

e64739d4-cbdd-4ed1-b6fc-3a1602573288

Public Version Date

December 01, 2021

Public Version Number

2

DI Record Publish Date

May 12, 2021

Additional Identifiers

Package DI Number

14251244500952

Quantity per Package

5

Contains DI Package

04251244500955

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