Axium QC-1.5-2-HELIX

GUDID 00836462010017

Detachable Coil System

Micro Therapeutics, Inc.

Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil

• Primary Device ID: 00836462010017
• NIH Device Record Key: e9d37487-5577-4a4b-9bee-97763ed044b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axium
• Version Model Number: QC-1.5-2-HELIX
• Catalog Number: QC-1.5-2-HELIX
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Length: 2 Centimeter
• Outer Diameter: 1.5 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 1.5 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 1.5 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 1.5 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 1.5 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 1.5 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 1.5 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 1.5 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 1.5 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 1.5 Millimeter
• Length: 2 Centimeter
• Outer Diameter: 1.5 Millimeter
• Length: 2 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462010017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133310

FDA Product Code

• KRD: Device, Vascular, for Promoting Embolization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-02
• Device Publish Date: 2015-10-16

On-Brand Devices [Axium]

• 00847536002012: Detachable Coil System
• 00847536002005: Detachable Coil System
• 00847536001992: Detachable Coil System
• 00847536001985: Detachable Coil System
• 00847536001978: Detachable Coil System
• 00847536001961: Detachable Coil System
• 00847536001954: Detachable Coil System
• 00847536001947: Detachable Coil System
• 00847536001930: Detachable Coil System
• 00847536001923: Detachable Coil System
• 00847536001916: Detachable Coil System
• 00847536001909: Detachable Coil System
• 00847536001893: Detachable Coil System
• 00847536001886: Detachable Coil System
• 00847536001879: Detachable Coil System
• 00836462010536: QC-22-50-3D BARE AXIUM 3D COIL
• 00836462010888: PC-8-20-3D AXIUM 3D 8MM X 20CM COIL
• 00836462010871: PC-7-30-3D AXIUM 3D 7MM X 30CM COIL
• 00836462010864: PC-7-20-3D AXIUM 3D 7MM X 20CM COIL
• 00836462010857: PC-6-20-3D AXIUM 3D 6MM X 20CM COIL
• 00836462010765: PC-10-30-HELIX AXIUM 10MMX30CM COIL
• 00836462010758: PC-9-30-HELIX AXIUM 9MM X 30CM
• 00836462010741: PC-8-30-HELIX AXIUM 8MM X 30CM
• 00836462010734: PC-7-30-HELIX AXIUM 7MM X 30CM
• 00836462010727: PC-6-20-HELIX AXIUM 6MM X 20CM
• 00836462010697: PC-4-12-HELIX AXIUM 4MM X 12CM
• 00836462010680: PC-4-10-HELIX AXIUM 4MM X 10CM
• 00836462010673: PC-4-8-HELIX AXIUM 4MM X 8CM COIL
• 00836462012615: PC-6-10-3D AXIUM 3D 6MM X 10CM
• 00836462012608: PC-5-8-3D AXIUM 3D 5MM X 8CM
• 00836462012592: PC-4-10-3D AXIUM 3D 4MM X 10CM
• 00836462012585: PC-4-6-3D AXIUM 3D 4MM X 6CM
• 00836462012578: QC-6-10-3D BARE AXIUM 3D COIL
• 00836462012561: QC-5-8-3D BARE AXIUM 3D COIL
• 00836462012554: QC-4-10-3D BARE AXIUM 3D COIL
• 00836462012547: QC-4-6-3D BARE AXIUM 3D COIL
• 00836462012530: PC-10-20-HELIX AXIUM HELIX 10MM X 20CM
• 00836462012523: PC-9-20-HELIX AXIUM HELIX 9MM X 20CM
• 00836462012516: PC-8-20-HELIX AXIUM HELIX 8MM X 20CM
• 00836462012479: QC-14-40-HELIX BARE AXIUM HELIX COIL
• 00836462012462: QC-12-40-HELIX BARE AXIUM HELIX COIL
• 00836462012455: QC-10-20-HELIX BARE AXIUM HELIX COIL
• 00836462012448: QC-9-20-HELIX BARE AXIUM HELIX COIL
• 00836462012431: QC-8-20-HELIX BARE AXIUM HELIX COIL
• 00836462012424: QC-7-20-HELIX BARE AXIUM HELIX COIL
• 00836462012417: QC-14-30-3D BARE AXIUM 3D COIL
• 00836462012400: QC-12-30-3D BARE AXIUM 3D COIL
• 00836462012394: QC-8-15-3D BARE AXIUM 3D COIL
• 00836462012387: QC-7-15-3D BARE AXIUM 3D COIL
• 00836462012196: PC-18-40-3D AXIUM 3D 18MM X 40CM