Axium QC-2-6-3D

GUDID 00836462010307

Detachable Coil System

Micro Therapeutics, Inc.

Neurovascular embolization coil

• Primary Device ID: 00836462010307
• NIH Device Record Key: 1f715b33-fd43-46cf-9144-ff345261be56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axium
• Version Model Number: QC-2-6-3D
• Catalog Number: QC-2-6-3D
• 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: 6 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462010307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081465

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: 3
• Public Version Date: 2018-07-06
• 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