AxiumTM

GUDID 00847536017153

QC-1.5-1-HELIX BARE AXIUM 1.5MM X 1CM

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 ID00847536017153
NIH Device Record Keyfac19b4f-7579-4ebf-b6bc-0854ad10323f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxiumTM
Version Model NumberQC-1.5-1-HELIX
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 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place not to exceed 50 degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847536017153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00847536017153]

Ethylene Oxide

[00847536017153]

Ethylene Oxide

[00847536017153]

Ethylene Oxide

[00847536017153]

Ethylene Oxide

[00847536017153]

Ethylene Oxide

[00847536017153]

Ethylene Oxide

[00847536017153]

Ethylene Oxide

[00847536017153]

Ethylene Oxide

[00847536017153]

Ethylene Oxide

[00847536017153]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-07

On-Brand Devices [AxiumTM]

00847536023734FRAMING COIL FC-25-50-3D V01
00847536023253FRAMING COIL FC-22-50-3D V01
00847536023239FRAMING COIL FC-20-50-3D V01
00847536023222FRAMING COIL FC-18-50-3D V01
00847536023215FRAMING COIL FC-18-40-3D V01
00847536023208FRAMING COIL FC-16-50-3D V01
00847536023192FRAMING COIL FC-16-40-3D V01
00847536023185FRAMING COIL FC-14-50-3D V01
00847536023178FRAMING COIL FC-14-40-3D V01
00847536023161FRAMING COIL FC-14-30-3D V01
00847536023154FRAMING COIL FC-12-50-3D V01
00847536023147FRAMING COIL FC-12-40-3D V01
00847536023130FRAMING COIL FC-12-30-3D V01
00847536023123FRAMING COIL FC-10-40-3D V01
00847536023116FRAMING COIL FC-10-30-3D V01
00847536023109FRAMING COIL FC-10-20-3D V01
00847536023093FRAMING COIL FC-9-30-3D V01
00847536023086FRAMING COIL FC-9-20-3D V01
00847536023079FRAMING COIL FC-8-30-3D V01
00847536023062FRAMING COIL FC-8-20-3D V01
00847536023055FRAMING COIL FC-8-15-3D V01
00847536023048FRAMING COIL FC-7-30-3D V01
00847536023031FRAMING COIL FC-7-20-3D V01
00847536023024FRAMING COIL FC-7-15-3D V01
00847536023017FRAMING COIL FC-7-12-3D V01
00847536023000FRAMING COIL FC-6-25-3D V01
00847536022997FRAMING COIL FC-6-20-3D V01
00847536022980FRAMING COIL FC-6-15-3D V01
00847536022973FRAMING COIL FC-6-10-3D V01
00847536022966FRAMING COIL FC-5-20-3D V01
00847536022959FRAMING COIL FC-5-15-3D V01
00847536022942FRAMING COIL FC-5-10-3D V01
00847536022935FRAMING COIL FC-5-8-3D V01
00847536022928FRAMING COIL FC-4-15-3D V01
00847536022911FRAMING COIL FC-4-12-3D V01
00847536022904FRAMING COIL FC-4-10-3D V01
00847536022898FRAMING COIL FC-4-8-3D V01
00847536022881FRAMING COIL FC-4-6-3D V01
00847536022867FRAMING COIL FC-3.5-10-3D V01
00847536022850FRAMING COIL FC-3.5-8-3D V01
00847536022843FRAMING COIL FC-3.5-6-3D V01
00847536022836FRAMING COIL FC-3-10-3D V01
00847536022829FRAMING COIL FC-3-8-3D V01
00847536022812FRAMING COIL FC-3-6-3D V01
00847536021938COIL APB-3.5-10-3D-ES V01
00847536021921COIL APB-3.5-8-3D-ES V01
00847536021914COIL APB-3.5-6-3D-ES V01
00847536021907COIL APB-3-8-3D-ES V01
00847536021891COIL APB-3-6-3D-ES V01
00847536021884COIL APB-3-4-3D-ES V01
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