DuraSheath Introducer Sheath System FG-04090

GUDID 24251244500126

Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.

Contract Medical International GmbH

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 24251244500126
• NIH Device Record Key: 38e3f2ae-932a-4155-b9d1-ea5a89de3282
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraSheath Introducer Sheath System
• Version Model Number: 4F, 90cm, straigth
• Catalog Number: FG-04090
• Company DUNS: 330926895
• Company Name: Contract Medical International GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +493512138888
• Email: regulatory@contract-medical.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com
• Phone: +493512138888
• Email: hmdd.regulatory@heraeus.com

Device Dimensions

• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 1.6 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251244500122 [Primary]
GS1	14251244500129 [Package]; Contains: 04251244500122; Package: Packer [5 Units]; In Commercial Distribution
GS1	24251244500126 [Package]; Contains: 14251244500129; Package: Corrugate [1 Units]; In Commercial Distribution

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-08
• Device Publish Date: 2019-06-30

Devices Manufactured by Contract Medical International GmbH

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• 14251244502772 - Catapult Guide Sheath: 2024-08-27 Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. Introducer Sheath is h
• 14251244502789 - Catapult Guide Sheath: 2024-08-27 Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. Introducer Sheath is h
• 14251244503601 - Biotronik Fortress Introducer Sheath System: 2024-07-02 Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators.
• 14251244503618 - Biotronik Fortress Introducer Sheath System: 2024-07-02 Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators.
• 14251244503625 - Biotronik Fortress Introducer Sheath System: 2024-07-02 Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators.
• 14251244503632 - Biotronik Fortress Introducer Sheath System: 2024-07-02 Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
• 14251244503649 - Biotronik Fortress Introducer Sheath System: 2024-07-02 Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.