Axium™ Detachable Coil System

GUDID 00763000488970

COIL PC-5-20-HELIX V12

Micro Therapeutics, Inc.

Neurovascular embolization coil

• Primary Device ID: 00763000488970
• NIH Device Record Key: 55d299b6-7d17-48f2-8fab-ba4fa3b0d915
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axium™ Detachable Coil System
• Version Model Number: PC-5-20-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: 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
• 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

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place, away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000488970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203432

FDA Product Code

• HCG: DEVICE, NEUROVASCULAR 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: 2022-11-07
• Device Publish Date: 2022-10-28

On-Brand Devices [Axium™ Detachable Coil System]

• 00763000494742: COIL PC-18-40-3D V11
• 00763000494735: COIL PC-16-40-3D V11
• 00763000494728: COIL PC-14-40-3D V11
• 00763000494711: COIL PC-14-30-3D V11
• 00763000494704: COIL PC-12-40-3D V11
• 00763000494698: COIL PC-12-30-3D V11
• 00763000494681: COIL PC-10-30-3D V11
• 00763000494674: COIL PC-10-20-3D V11
• 00763000494667: COIL PC-9-30-3D V11
• 00763000494650: COIL PC-9-20-3D V11
• 00763000494643: COIL PC-8-30-3D V11
• 00763000494636: COIL PC-8-20-3D V11
• 00763000494629: COIL PC-8-15-3D V11
• 00763000494612: COIL PC-7-30-3D V11
• 00763000494605: COIL PC-7-20-3D V11
• 00763000494599: COIL PC-7-15-3D V11
• 00763000494582: COIL PC-6-20-3D V11
• 00763000494575: COIL PC-6-15-3D V11
• 00763000494568: COIL PC-6-10-3D V11
• 00763000494551: COIL PC-5-15-3D V11
• 00763000494544: COIL PC-5-10-3D V11
• 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
• 00763000494452: COIL PC-2-6-3D V11
• 00763000494445: COIL PC-2-4-3D V11
• 00763000494438: COIL PC-2-2-3D V11
• 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