Axium PrimeTM

GUDID 00847536034105

COIL FC-3.5-10-3D V03

Micro Therapeutics, Inc.

Neurovascular embolization coil

• Primary Device ID: 00847536034105
• NIH Device Record Key: 5e7f9a73-7983-4535-9b88-1fca1b4b6b13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axium PrimeTM
• Version Model Number: FC-3.5-10-3D
• 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
• 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 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536034105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162704

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: 2019-06-28
• Device Publish Date: 2019-06-20

On-Brand Devices [Axium PrimeTM]

• 00847536034488: COIL FC-25-50-3D V03
• 00847536034471: COIL FC-22-50-3D V03
• 00847536034464: COIL FC-20-50-3D V03
• 00847536034457: COIL FC-18-50-3D V03
• 00847536034440: COIL FC-18-40-3D V03
• 00847536034433: COIL FC-16-50-3D V03
• 00847536034426: COIL FC-16-40-3D V03
• 00847536034419: COIL FC-14-50-3D V03
• 00847536034402: COIL FC-14-40-3D V03
• 00847536034396: COIL FC-14-30-3D V03
• 00847536034389: COIL FC-12-50-3D V03
• 00847536034372: COIL FC-12-40-3D V03
• 00847536034365: COIL FC-12-30-3D V03
• 00847536034358: COIL FC-10-40-3D V03
• 00847536034341: COIL FC-10-30-3D V03
• 00847536034334: COIL FC-10-20-3D V03
• 00847536034327: COIL FC-9-30-3D V03
• 00847536034310: COIL FC-9-20-3D V03
• 00847536034303: COIL FC-8-30-3D V03
• 00847536034297: COIL FC-8-20-3D V03
• 00847536034280: COIL FC-8-15-3D V03
• 00847536034273: COIL FC-7-30-3D V03
• 00847536034266: COIL FC-7-20-3D V03
• 00847536034259: COIL FC-7-15-3D V03
• 00847536034242: COIL FC-7-12-3D V03
• 00847536034235: COIL FC-6-25-3D V03
• 00847536034228: COIL FC-6-20-3D V03
• 00847536034211: COIL FC-6-15-3D V03
• 00847536034204: COIL FC-6-10-3D V03
• 00847536034198: COIL FC-5-20-3D V03
• 00847536034181: COIL FC-5-15-3D V03
• 00847536034174: COIL FC-5-10-3D V03
• 00847536034167: COIL FC-5-8-3D V03
• 00847536034150: COIL FC-4-15-3D V03
• 00847536034143: COIL FC-4-12-3D V03
• 00847536034136: COIL FC-4-10-3D V03
• 00847536034129: COIL FC-4-8-3D V03
• 00847536034112: COIL FC-4-6-3D V03
• 00847536034105: COIL FC-3.5-10-3D V03
• 00847536034099: COIL FC-3.5-8-3D V03
• 00847536034082: COIL FC-3.5-6-3D V03
• 00847536034075: COIL FC-3-10-3D V03
• 00847536034068: COIL FC-3-8-3D V03
• 00847536034051: COIL FC-3-6-3D V03
• 00847536032378: COIL APB-6-20-HX-SS V04
• 00847536032361: COIL APB-6-12-HX-SS V04
• 00847536032354: COIL APB-5-20-HX-SS V04
• 00847536032347: COIL APB-5-15-HX-SS V04
• 00847536032330: COIL APB-5-10-HX-SS V04
• 00847536032323: COIL APB-4-12-HX-SS V04