AxiumTM

GUDID 00847536014251

PC-3-8-HELIX PGLA AXIUM 3MM X 8CM

Micro Therapeutics, Inc.

Neurovascular embolization coil

• Primary Device ID: 00847536014251
• NIH Device Record Key: 323cd60f-5db8-46da-9462-15dddc3d151a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AxiumTM
• Version Model Number: PC-3-8-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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536014251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081465

FDA Product Code

• KRD: Device, Vascular, for Promoting Embolization

Sterilization

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

[00847536014251]

Ethylene Oxide

[00847536014251]

Ethylene Oxide

[00847536014251]

Ethylene Oxide

[00847536014251]

Ethylene Oxide

[00847536014251]

Ethylene Oxide

[00847536014251]

Ethylene Oxide

[00847536014251]

Ethylene Oxide

[00847536014251]

Ethylene Oxide

[00847536014251]

Ethylene Oxide

[00847536014251]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-30
• Device Publish Date: 2015-09-07

On-Brand Devices [AxiumTM]

• 00847536023734: FRAMING COIL FC-25-50-3D V01
• 00847536023253: FRAMING COIL FC-22-50-3D V01
• 00847536023239: FRAMING COIL FC-20-50-3D V01
• 00847536023222: FRAMING COIL FC-18-50-3D V01
• 00847536023215: FRAMING COIL FC-18-40-3D V01
• 00847536023208: FRAMING COIL FC-16-50-3D V01
• 00847536023192: FRAMING COIL FC-16-40-3D V01
• 00847536023185: FRAMING COIL FC-14-50-3D V01
• 00847536023178: FRAMING COIL FC-14-40-3D V01
• 00847536023161: FRAMING COIL FC-14-30-3D V01
• 00847536023154: FRAMING COIL FC-12-50-3D V01
• 00847536023147: FRAMING COIL FC-12-40-3D V01
• 00847536023130: FRAMING COIL FC-12-30-3D V01
• 00847536023123: FRAMING COIL FC-10-40-3D V01
• 00847536023116: FRAMING COIL FC-10-30-3D V01
• 00847536023109: FRAMING COIL FC-10-20-3D V01
• 00847536023093: FRAMING COIL FC-9-30-3D V01
• 00847536023086: FRAMING COIL FC-9-20-3D V01
• 00847536023079: FRAMING COIL FC-8-30-3D V01
• 00847536023062: FRAMING COIL FC-8-20-3D V01
• 00847536023055: FRAMING COIL FC-8-15-3D V01
• 00847536023048: FRAMING COIL FC-7-30-3D V01
• 00847536023031: FRAMING COIL FC-7-20-3D V01
• 00847536023024: FRAMING COIL FC-7-15-3D V01
• 00847536023017: FRAMING COIL FC-7-12-3D V01
• 00847536023000: FRAMING COIL FC-6-25-3D V01
• 00847536022997: FRAMING COIL FC-6-20-3D V01
• 00847536022980: FRAMING COIL FC-6-15-3D V01
• 00847536022973: FRAMING COIL FC-6-10-3D V01
• 00847536022966: FRAMING COIL FC-5-20-3D V01
• 00847536022959: FRAMING COIL FC-5-15-3D V01
• 00847536022942: FRAMING COIL FC-5-10-3D V01
• 00847536022935: FRAMING COIL FC-5-8-3D V01
• 00847536022928: FRAMING COIL FC-4-15-3D V01
• 00847536022911: FRAMING COIL FC-4-12-3D V01
• 00847536022904: FRAMING COIL FC-4-10-3D V01
• 00847536022898: FRAMING COIL FC-4-8-3D V01
• 00847536022881: FRAMING COIL FC-4-6-3D V01
• 00847536022867: FRAMING COIL FC-3.5-10-3D V01
• 00847536022850: FRAMING COIL FC-3.5-8-3D V01
• 00847536022843: FRAMING COIL FC-3.5-6-3D V01
• 00847536022836: FRAMING COIL FC-3-10-3D V01
• 00847536022829: FRAMING COIL FC-3-8-3D V01
• 00847536022812: FRAMING COIL FC-3-6-3D V01
• 00847536021938: COIL APB-3.5-10-3D-ES V01
• 00847536021921: COIL APB-3.5-8-3D-ES V01
• 00847536021914: COIL APB-3.5-6-3D-ES V01
• 00847536021907: COIL APB-3-8-3D-ES V01
• 00847536021891: COIL APB-3-6-3D-ES V01
• 00847536021884: COIL APB-3-4-3D-ES V01