Axium™ Detachable Coil System

GUDID 00763000845902

COIL QC-5-10-3D V14

Micro Therapeutics, Inc.

Neurovascular embolization coil

• Primary Device ID: 00763000845902
• NIH Device Record Key: 778a536d-a060-49c1-91ff-73017bef3403
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axium™ Detachable Coil System
• Version Model Number: QC-5-10-3D
• 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: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000845902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233420

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-06
• Device Publish Date: 2024-12-28

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• 00763000494537: COIL PC-5-8-3D V11
• 00763000494520: COIL PC-4-12-3D V11
• 00763000494513: COIL PC-4-10-3D V11
• 00763000494506: COIL PC-4-8-3D V11
• 00763000494490: COIL PC-4-6-3D V11
• 00763000494483: COIL PC-3-8-3D V11
• 00763000494476: COIL PC-3-6-3D V11
• 00763000494469: COIL PC-3-4-3D V11
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• 00763000494445: COIL PC-2-4-3D V11
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• 00763000494421: COIL PC-10-30-HELIX V11
• 00763000494414: COIL PC-10-20-HELIX V11
• 00763000494407: COIL PC-9-30-HELIX V11
• 00763000494391: COIL PC-9-20-HELIX V11
• 00763000494384: COIL PC-8-30-HELIX V11
• 00763000494377: COIL PC-8-20-HELIX V11
• 00763000494360: COIL PC-7-30-HELIX V11
• 00763000494353: COIL PC-7-20-HELIX V11
• 00763000494346: COIL PC-6-20-HELIX V11
• 00763000494339: COIL PC-5-20-HELIX V11
• 00763000494322: COIL PC-5-15-HELIX V11
• 00763000494315: COIL PC-4-12-HELIX V11
• 00763000494308: COIL PC-4-10-HELIX V11
• 00763000494292: COIL PC-4-8-HELIX V11
• 00763000494285: COIL PC-3-8-HELIX V11
• 00763000494278: COIL PC-3-6-HELIX V11
• 00763000494261: COIL PC-3-4-HELIX V11
• 00763000494254: COIL PC-2-8-HELIX V11