Axium PrimeTM

GUDID 00847536031821

COIL APB-1-3-3D-ES V04

Micro Therapeutics, Inc.

Neurovascular embolization coil
Primary Device ID00847536031821
NIH Device Record Keyca93d8ed-908d-444a-9cca-fbd07bbb8302
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxium PrimeTM
Version Model NumberAPB-1-3-3D-ES
Company DUNS826110710
Company NameMicro Therapeutics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Store product in a dry, cool place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100847536031821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRDDevice, Vascular, for Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-28
Device Publish Date2019-06-20

On-Brand Devices [Axium PrimeTM]

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

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