Biotronik Fortress Introducer Sheath System 386591

GUDID 14251244500044

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

Contract Medical International GmbH

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• Primary Device ID: 14251244500044
• NIH Device Record Key: 214e8991-a20c-4f2b-9332-e4bb53507562
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotronik Fortress Introducer Sheath System
• Version Model Number: 45 cm, 5F Straight
• Catalog Number: 386591
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com
• Phone: +410448645111
• Email: info.vi@biotronik.com

Device Dimensions

• Lumen/Inner Diameter: 1.95 Millimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter
• Length: 45 Centimeter
• Lumen/Inner Diameter: 1.95 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251244500047 [Primary]
GS1	14251244500044 [Package]; Contains: 04251244500047; Package: Packer [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153197

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-06-30

On-Brand Devices [Biotronik Fortress Introducer Sheath System]

• 14251244500600: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500594: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500587: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500570: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500563: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 04251244500559: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500099: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500082: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
• 14251244500075: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500068: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500051: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
• 14251244500044: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500037: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
• 04251244500023: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
• 14251244500013: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)