Axium™ Prime Detachable Coil System

GUDID 00763000495183

COIL APB-2-8-HX-ES V11

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 Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil
Primary Device ID00763000495183
NIH Device Record Keyf3b94e7f-d2b9-4d99-af36-147b4023e8aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxium™ Prime Detachable Coil System
Version Model NumberAPB-2-8-HX-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
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 dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place, away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000495183 [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 Date2022-11-07
Device Publish Date2022-10-28

On-Brand Devices [Axium™ Prime Detachable Coil System]

00763000495350COIL APB-6-20-HX-SS V11
00763000495343COIL APB-6-12-HX-SS V11
00763000495336COIL APB-5-20-HX-SS V11
00763000495329COIL APB-5-15-HX-SS V11
00763000495312COIL APB-5-10-HX-SS V11
00763000495305COIL APB-4-12-HX-SS V11
00763000495299COIL APB-4-10-HX-SS V11
00763000495282COIL APB-4-8-HX-SS V11
00763000495275COIL APB-4-6-HX-SS V11
00763000495268COIL APB-3-10-HX-ES V11
00763000495251COIL APB-3-8-HX-ES V11
00763000495244COIL APB-3-6-HX-ES V11
00763000495237COIL APB-3-4-HX-ES V11
00763000495220COIL APB-2.5-8-HX-ES V11
00763000495213COIL APB-2.5-6-HX-ES V11
00763000495206COIL APB-2.5-4-HX-ES V11
00763000495190COIL APB-2.5-3-HX-ES V11
00763000495183COIL APB-2-8-HX-ES V11
00763000495176COIL APB-2-6-HX-ES V11
00763000495169COIL APB-2-4-HX-ES V11
00763000495152COIL APB-2-3-HX-ES V11
00763000495145COIL APB-2-2-HX-ES V11
00763000495138COIL APB-2-1-HX-ES V11
00763000495121COIL APB-1.5-4-HX-ES V11
00763000495114COIL APB-1.5-3-HX-ES V11
00763000495107COIL APB-1.5-2-HX-ES V11
00763000495091COIL APB-1.5-1-HX-ES V11
00763000495084COIL APB-1-3-HX-ES V11
00763000495077COIL APB-1-2-HX-ES V11
00763000495060COIL APB-1-1-HX-ES V11
00763000495053COIL APB-6-20-3D-SS V11
00763000495046COIL APB-6-15-3D-SS V11
00763000495039COIL APB-6-10-3D-SS V11
00763000495022COIL APB-5-15-3D-SS V11
00763000495015COIL APB-5-10-3D-SS V11
00763000495008COIL APB-5-8-3D-SS V11
00763000494995COIL APB-4-12-3D-SS V11
00763000494988COIL APB-4-10-3D-SS V11
00763000494971COIL APB-4-8-3D-SS V11
00763000494964COIL APB-4-6-3D-SS V11
00763000494957COIL APB-3.5-10-3D-ES V11
00763000494940COIL APB-3.5-8-3D-ES V11
00763000494933COIL APB-3.5-6-3D-ES V11
00763000494926COIL APB-3-8-3D-ES V11
00763000494919COIL APB-3-6-3D-ES V11
00763000494902COIL APB-3-4-3D-ES V11
00763000494896COIL APB-2.5-6-3D-ES V11
00763000494889COIL APB-2.5-4-3D-ES V11
00763000494872COIL APB-2-4-3D-ES V11
00763000494865COIL APB-2-3-3D-ES V11

Trademark Results [Axium]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AXIUM
AXIUM
97769154 not registered Live/Pending
Axium Solutions ULC
2023-01-26
AXIUM
AXIUM
97763019 not registered Live/Pending
Year33 Inc.
2023-01-20
AXIUM
AXIUM
90596375 not registered Live/Pending
Vadovations, Inc.
2021-03-23
AXIUM
AXIUM
88381237 not registered Live/Pending
KINETICO INCORPORATED
2019-04-11
AXIUM
AXIUM
87338441 not registered Dead/Abandoned
L18 Holdings, Inc.
2017-02-16
AXIUM
AXIUM
85872397 not registered Dead/Abandoned
Automatic Equipment Manufacturing Company
2013-03-11
AXIUM
AXIUM
85463170 4564567 Live/Registered
Spinal Modulation, Inc.
2011-11-03
AXIUM
AXIUM
85194906 3997317 Dead/Cancelled
Master Brands HK Limited
2010-12-10
AXIUM
AXIUM
85194877 3997315 Dead/Cancelled
Master Brands HK Limited
2010-12-10
AXIUM
AXIUM
79243756 not registered Live/Pending
INGENICO GROUP
2018-07-09
AXIUM
AXIUM
78761181 not registered Dead/Abandoned
Axium Management, Inc.
2005-11-27
AXIUM
AXIUM
78748165 3540355 Live/Registered
Axium Consulting LLC
2005-11-07
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