DuraSheath Introducer Sheath System FG-06090-F

GUDID 24251244500652

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: 24251244500652
• NIH Device Record Key: 2b2176fe-ec11-4055-afea-7e7e7c0c2ee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraSheath Introducer Sheath System
• Version Model Number: 6F, 90cm, straigth, firm
• Catalog Number: FG-06090-F
• 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: 2.25 Millimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter
• Length: 90 Centimeter
• Lumen/Inner Diameter: 2.25 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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	04251244500658 [Primary]
GS1	14251244500655 [Package]; Contains: 04251244500658; Package: Packer [5 Units]; In Commercial Distribution
GS1	24251244500652 [Package]; Contains: 14251244500655; 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-07
• Device Publish Date: 2019-02-12

On-Brand Devices [DuraSheath Introducer Sheath System]

• 24251244500652: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 04251244500634: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 04251244500160: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 24251244500621: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
• 24251244500614: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
• 24251244500485: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
• 24251244500478: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 24251244500461: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 24251244500454: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 24251244500447: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 24251244500317: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 24251244500300: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 24251244500188: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 24251244500171: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 24251244500157: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 24251244500140: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 24251244500133: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 24251244500119: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 24251244500102: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500792: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244501096: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 04251244501082: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 04251244501075: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500853: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500846: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500839: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500815: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500808: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500716: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
• 14251244500648: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)