Axium Prime Detachable Coil System

GUDID 00763000313616

COIL APB 1-2 3D-ES V06

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 Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil
Primary Device ID00763000313616
NIH Device Record Key169b6117-c08c-4c34-9a00-2a676b2c3e9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxium Prime Detachable Coil System
Version Model NumberAPB-1-2-3D-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
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 *store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000313616 [Primary]
GS100763000313616 [Primary]
GS100763000313616 [Primary]
GS100763000313616 [Primary]
GS100763000313616 [Primary]
GS100763000313616 [Primary]
GS100763000313616 [Primary]
GS100763000313616 [Primary]
GS100763000313616 [Primary]
GS100763000313616 [Primary]
GS100763000313616 [Primary]
GS100763000313616 [Primary]
GS100763000313616 [Primary]
GS100763000313616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCGDEVICE, NEUROVASCULAR EMBOLIZATION
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

On-Brand Devices [Axium Prime Detachable Coil System]

00847536039049COIL FC-25-50-3D V05
00847536039032COIL FC-22-50-3D V05
00847536039025COIL FC-20-50-3D V05
00847536039018COIL FC-18-50-3D V05
00847536039001COIL FC-18-40-3D V05
00847536038998COIL FC-16-50-3D V05
00847536038981COIL FC-16-40-3D V05
00847536038974COIL FC-14-50-3D V05
00847536038967COIL FC-14-40-3D V05
00847536038950COIL FC-14-30-3D V05
00847536038943COIL FC-12-50-3D V05
00847536038936COIL FC-12-40-3D V05
00847536038929COIL FC-12-30-3D V05
00847536038912COIL FC-10-40-3D V05
00847536038905COIL FC-10-30-3D V05
00847536038899COIL FC-10-20-3D V05
00847536038882COIL FC-9-30-3D V05
00847536038875COIL FC-9-20-3D V05
00847536038868COIL FC-8-30-3D V05
00847536038851COIL FC-8-20-3D V05
00847536038844COIL FC-8-15-3D V05
00847536038837COIL FC-7-30-3D V05
00847536038820COIL FC-7-20-3D V05
00847536038813COIL FC-7-15-3D V05
00847536038806COIL FC-7-12-3D V05
00847536038790COIL FC-6-25-3D V05
00847536038783COIL FC-6-20-3D V05
00847536038776COIL FC-6-15-3D V05
00847536038769COIL FC-6-10-3D V05
00847536038752COIL FC-5-20-3D V05
00847536038745COIL FC-5-15-3D V05
00847536038738COIL FC-5-10-3D V05
00847536038721COIL FC-5-8-3D V05
00847536038714COIL FC-4-15-3D V05
00847536038707COIL FC-4-12-3D V05
00847536038691COIL FC-4-10-3D V05
00847536038684COIL FC-4-8-3D V05
00847536038677COIL FC-4-6-3D V05
00847536038660COIL FC-3.5-10-3D V05
00847536038653COIL FC-3.5-8-3D V05
00847536038646COIL FC-3.5-6-3D V05
00847536038639COIL FC-3-10-3D V05
00847536038622COIL FC-3-8-3D V05
00847536038615COIL FC-3-6-3D V05
00847536038608COIL APB-6-20-HX-SS V05
00847536038592COIL APB-6-12-HX-SS V05
00847536038585COIL APB-5-20-HX-SS V05
00847536038578COIL APB-5-15-HX-SS V05
00847536038561COIL APB-5-10-HX-SS V05
00847536038554COIL APB-4-12-HX-SS V05

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