Axium PrimeTM

GUDID 00847536034365

COIL FC-12-30-3D V03

Micro Therapeutics, Inc.

Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil

• Primary Device ID: 00847536034365
• NIH Device Record Key: 83dfc7e2-95f3-4a9d-b1dd-ed22573710f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axium PrimeTM
• Version Model Number: FC-12-30-3D
• 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

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536034365 [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