AvigoTM

GUDID 00847536004764

103-0606-200 AVIGO GWIRE 205CM CE

Micro Therapeutics, Inc.

Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual

Primary Device ID	00847536004764
NIH Device Record Key	a27457b8-9e53-492c-b73e-542eecd8e69e
Commercial Distribution Status	In Commercial Distribution
Brand Name	AvigoTM
Version Model Number	103-0606-200
Company DUNS	826110710
Company Name	Micro Therapeutics, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
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

Operating and Storage Conditions

Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536004764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K113454

FDA Product Code

DQX	WIRE, GUIDE, CATHETER

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

[00847536004764]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-08-04

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00847536036246 - PipelineTM Vantage Embolization Device with Shield TechnologyTM	2024-01-08 STENT PED3-021-250-16 V03 VANTAGE
00847536036253 - PipelineTM Vantage Embolization Device with Shield TechnologyTM	2024-01-08 STENT PED3-021-250-18 V03 VANTAGE
00847536036260 - PipelineTM Vantage Embolization Device with Shield TechnologyTM	2024-01-08 STENT PED3-021-250-20 V03 VANTAGE
00847536036277 - PipelineTM Vantage Embolization Device with Shield TechnologyTM	2024-01-08 STENT PED3-021-275-10 V03 VANTAGE
00847536036284 - PipelineTM Vantage Embolization Device with Shield TechnologyTM	2024-01-08 STENT PED3-021-275-12 V03 VANTAGE