AvigoTM

GUDID 00847536004764

103-0606-200 AVIGO GWIRE 205CM CE

Micro Therapeutics, Inc.

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

Devices Manufactured by Micro Therapeutics, Inc.

• 00763000518905 - Avigo: 2024-10-29 GUIDEWIRE 103-0606-200 V05 AVIGO MDR
• 00763000518912 - Mirage: 2024-10-29 GUIDEWIRE 103-0608 V09 MIRAGE MDR
• 00763000518929 - X-Pedion: 2024-10-29 GUIDEWIRE 103-0605-200 V09 X-PEDION MDR
• 00763000412487 - Rebar: 2024-08-16 MICRO CATH 105-5081-153 V05 REBAR
• 00847536036215 - PipelineTM Vantage Embolization Device with Shield TechnologyTM: 2024-01-08 STENT PED3-021-250-10 V03 VANTAGE
• 00847536036222 - PipelineTM Vantage Embolization Device with Shield TechnologyTM: 2024-01-08 STENT PED3-021-250-12 V03 VANTAGE
• 00847536036239 - PipelineTM Vantage Embolization Device with Shield TechnologyTM: 2024-01-08 STENT PED3-021-250-14 V03 VANTAGE
• 00847536036246 - PipelineTM Vantage Embolization Device with Shield TechnologyTM: 2024-01-08 STENT PED3-021-250-16 V03 VANTAGE