ConcertoTM

GUDID 00847536033528

COIL NV-3-8-HELIX V06

Micro Therapeutics, Inc.

Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil

• Primary Device ID: 00847536033528
• NIH Device Record Key: d6b1ad57-9a36-4ad0-a170-62399d32c9ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ConcertoTM
• Version Model Number: NV-3-8-HELIX
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536033528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081465

FDA Product Code

• KRD: Device, Vascular, for Promoting Embolization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-02
• Device Publish Date: 2019-06-24

On-Brand Devices [ConcertoTM]

• 00847536026520: COIL PV-18-40-3D CONCERTO 3D V01
• 00847536026513: COIL PV-16-40-3D CONCERTO 3D V01
• 00847536026506: COIL PV-14-40-3D CONCERTO 3D V01
• 00847536026490: COIL PV-12-40-3D CONCERTO 3D V01
• 00847536026483: COIL PV-10-30-3D CONCERTO 3D V01
• 00847536026476: COIL PV-10-20-3D CONCERTO 3D V01
• 00847536026469: COIL PV-9-30-3D CONCERTO 3D V01
• 00847536026452: COIL PV-9-20-3D CONCERTO 3D V01
• 00847536026445: COIL PV-8-30-3D CONCERTO 3D V01
• 00847536026438: COIL PV-8-20-3D CONCERTO 3D V01
• 00847536026421: COIL PV-7-30-3D CONCERTO 3D V01
• 00847536026414: COIL PV-7-20-3D CONCERTO 3D V01
• 00847536026407: COIL PV-6-20-3D CONCERTO 3D V01
• 00847536026391: COIL PV-6-15-3D CONCERTO 3D V01
• 00847536026384: COIL PV-5-15-3D CONCERTO 3D V01
• 00847536026377: COIL PV-5-10-3D CONCERTO 3D V01
• 00847536026360: COIL PV-4-12-3D CONCERTO 3D V01
• 00847536026353: COIL PV-4-10-3D CONCERTO 3D V01
• 00847536026346: COIL PV-4-8-3D CONCERTO 3D V01
• 00847536026339: COIL PV-3-8-3D V01 CONCERTO 3D
• 00847536026322: COIL PV-3-6-3D V01 CONCERTO 3D
• 00847536026315: COIL PV-3-4-3D V01 CONCERTO 3D
• 00847536026308: COIL PV-2-6-3D V01 CONCERTO 3D
• 00847536026292: COIL PV-2-4-3D V01 CONCERTO 3D
• 00847536026285: COIL PV-2-2-3D V01 CONCERTO 3D
• 00847536017146: CONCERTO HELIX 20MM X 50CM PGLA COIL
• 00847536017122: CONCERTO HELIX 20MM X 50CM PGLA COIL
• 00847536017108: CONCERTO HELIX 18MM X 40CM PGLA COIL
• 00847536017085: CONCERTO HELIX 18MM X 40CM PGLA COIL
• 00847536017078: CONCERTO HELIX 16MM X 40CM PGLA COIL
• 00847536017054: CONCERTO HELIX 16MM X 40CM PGLA COIL
• 00847536017047: PV-14-40-HELIX CONCERTO PGLA COIL
• 00847536017023: PV-14-40-HELIX CONCERTO PGLA COIL
• 00847536017016: CONCERTO HELIX 14MM X 30CM PGLA COIL
• 00847536016996: CONCERTO HELIX 14MM X 30CM PGLA COIL
• 00847536016972: PV-12-40-HELIX CONCERTO PGLA COIL
• 00847536016958: PV-12-40-HELIX CONCERTO PGLA COIL
• 00847536016941: CONCERTO HELIX 12MM X 30CM PGLA COIL
• 00847536016927: CONCERTO HELIX 12MM X 30CM PGLA COIL
• 00847536013766: CONCERTO HELIX 9MM X 30CM NYLON COIL
• 00847536013742: CONCERTO HELIX 9MM X 30CM NYLON COIL
• 00847536013735: NV-9-20-HELIX CONCERTO HELIX 9MMX20CM
• 00847536013711: NV-9-20-HELIX CONCERTO HELIX 9MMX20CM
• 00847536013704: NV-8-30-HELIX CONCERTO HELIX 8MMX30CM
• 00847536013681: NV-8-30-HELIX CONCERTO HELIX 8MMX30CM
• 00847536013674: CONCERTO HELIX 8MM X 20CM NYLON COIL
• 00847536013650: NV-8-20-HELIX CONCERTO HELIX 8MMX20CM
• 00847536013643: NYLON COIL NV-7-30-HELIX 7MM X 30CM
• 00847536013629: NV-7-30-HELIX CONCERTO HELIX 7MMX30CM
• 00847536013612: NV-7-20-HELIX CONCERTO HELIX 7MMX20CM