Axium™ Prime Detachable Coil System

GUDID 00763000495060

COIL APB-1-1-HX-ES V11

Micro Therapeutics, Inc.

Neurovascular embolization coil

• Primary Device ID: 00763000495060
• NIH Device Record Key: 1f88e5ef-9856-4c89-a011-ec3e7db57d20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axium™ Prime Detachable Coil System
• Version Model Number: APB-1-1-HX-ES
• 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

• 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.
• 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	00763000495060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203432

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: 2022-11-07
• Device Publish Date: 2022-10-28

On-Brand Devices [Axium™ Prime Detachable Coil System]

• 00763000495350: COIL APB-6-20-HX-SS V11
• 00763000495343: COIL APB-6-12-HX-SS V11
• 00763000495336: COIL APB-5-20-HX-SS V11
• 00763000495329: COIL APB-5-15-HX-SS V11
• 00763000495312: COIL APB-5-10-HX-SS V11
• 00763000495305: COIL APB-4-12-HX-SS V11
• 00763000495299: COIL APB-4-10-HX-SS V11
• 00763000495282: COIL APB-4-8-HX-SS V11
• 00763000495275: COIL APB-4-6-HX-SS V11
• 00763000495268: COIL APB-3-10-HX-ES V11
• 00763000495251: COIL APB-3-8-HX-ES V11
• 00763000495244: COIL APB-3-6-HX-ES V11
• 00763000495237: COIL APB-3-4-HX-ES V11
• 00763000495220: COIL APB-2.5-8-HX-ES V11
• 00763000495213: COIL APB-2.5-6-HX-ES V11
• 00763000495206: COIL APB-2.5-4-HX-ES V11
• 00763000495190: COIL APB-2.5-3-HX-ES V11
• 00763000495183: COIL APB-2-8-HX-ES V11
• 00763000495176: COIL APB-2-6-HX-ES V11
• 00763000495169: COIL APB-2-4-HX-ES V11
• 00763000495152: COIL APB-2-3-HX-ES V11
• 00763000495145: COIL APB-2-2-HX-ES V11
• 00763000495138: COIL APB-2-1-HX-ES V11
• 00763000495121: COIL APB-1.5-4-HX-ES V11
• 00763000495114: COIL APB-1.5-3-HX-ES V11
• 00763000495107: COIL APB-1.5-2-HX-ES V11
• 00763000495091: COIL APB-1.5-1-HX-ES V11
• 00763000495084: COIL APB-1-3-HX-ES V11
• 00763000495077: COIL APB-1-2-HX-ES V11
• 00763000495060: COIL APB-1-1-HX-ES V11
• 00763000495053: COIL APB-6-20-3D-SS V11
• 00763000495046: COIL APB-6-15-3D-SS V11
• 00763000495039: COIL APB-6-10-3D-SS V11
• 00763000495022: COIL APB-5-15-3D-SS V11
• 00763000495015: COIL APB-5-10-3D-SS V11
• 00763000495008: COIL APB-5-8-3D-SS V11
• 00763000494995: COIL APB-4-12-3D-SS V11
• 00763000494988: COIL APB-4-10-3D-SS V11
• 00763000494971: COIL APB-4-8-3D-SS V11
• 00763000494964: COIL APB-4-6-3D-SS V11
• 00763000494957: COIL APB-3.5-10-3D-ES V11
• 00763000494940: COIL APB-3.5-8-3D-ES V11
• 00763000494933: COIL APB-3.5-6-3D-ES V11
• 00763000494926: COIL APB-3-8-3D-ES V11
• 00763000494919: COIL APB-3-6-3D-ES V11
• 00763000494902: COIL APB-3-4-3D-ES V11
• 00763000494896: COIL APB-2.5-6-3D-ES V11
• 00763000494889: COIL APB-2.5-4-3D-ES V11
• 00763000494872: COIL APB-2-4-3D-ES V11
• 00763000494865: COIL APB-2-3-3D-ES V11