Axium PrimeTM

GUDID 00847536034396

COIL FC-14-30-3D V03

Micro Therapeutics, Inc.

Neurovascular embolization coil

Primary Device ID	00847536034396
NIH Device Record Key	91801b00-13a5-4830-9a3d-dc67c3b3c8b4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Axium PrimeTM
Version Model Number	FC-14-30-3D
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
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.
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	00847536034396 [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