Biotronik Fortress Introducer Sheath System 358815

GUDID 04251244500023

Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators.

Contract Medical International GmbH

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 04251244500023
• NIH Device Record Key: 3d19c68b-ef61-4018-810a-f004adcd64db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotronik Fortress Introducer Sheath System
• Version Model Number: 100 cm, 4F Straight
• Catalog Number: 358815
• 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

• Length: 100 Centimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter
• Lumen/Inner Diameter: 1.62 Millimeter
• Length: 100 Centimeter

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	04251244500023 [Primary]
GS1	14251244500020 [Package]; Package: Packer [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100799

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)
• 14251244503847: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503830: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503823: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503809: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503793: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503786: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503779: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503755: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503748: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503731: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503724: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503717: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
• 14251244503700: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503694: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503687: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503670: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503663: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
• 14251244503656: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503649: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503632: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244503625: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
• 14251244503618: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
• 14251244503601: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)