Concerto Detachable Coil System

GUDID 00847536044906

COIL NV-3-8-HELIX V07

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 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 Non-neurovascular embolization coil Non-neurovascular embolization coil

• Primary Device ID: 00847536044906
• NIH Device Record Key: 77a98ebe-32b1-4dfb-bdc7-32eb6c7655fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Concerto Detachable Coil System
• 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
• 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 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store in a cool dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536044906 [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: 2020-10-02
• Device Publish Date: 2020-09-24

On-Brand Devices [Concerto Detachable Coil System]

• 00847536044982: COIL NV-9-30-HELIX V07
• 00847536044968: COIL NV-7-30-HELIX V07
• 00847536044951: COIL NV-6-20-HELIX V07
• 00847536044944: COIL NV-5-20-HELIX V07
• 00847536044937: COIL NV-5-15-HELIX V07
• 00847536044920: COIL NV-4-10-HELIX V07
• 00847536044913: COIL NV-4-8-HELIX V07
• 00847536044906: COIL NV-3-8-HELIX V07
• 00847536044869: COIL NV-2-4-HELIX V07
• 00763000307240: COIL NV-10-20-HELIX V07
• 00763000307226: COIL NV-8-20-HELIX V07
• 00763000307219: COIL NV-7-20-HELIX V07
• 00763000307202: COIL NV-6-12-HELIX V07
• 00763000307233: COIL NV-9-20-HELIX V07
• 00763000307196: COIL NV-5-10-HELIX V07
• 00847536044999: COIL NV-10-30-HELIX V07
• 00847536044975: COIL NV-8-30-HELIX V07
• 00847536044890: COIL NV-3-4-HELIX V07
• 00847536044883: COIL NV-2-8-HELIX V07
• 00847536044876: COIL NV-2-6-HELIX V07
• 00847536045347: COIL PV-18-40-3D V05
• 00847536045330: COIL PV-16-40-3D V05
• 00847536045323: COIL PV-14-40-3D V05
• 00847536045316: COIL PV-12-40-3D V05
• 00847536045200: COIL PV-10-30-3D V05
• 00847536045194: COIL PV-9-30-3D V05
• 00847536045187: COIL PV-8-30-3D V05
• 00847536045170: COIL PV-7-30-3D V05
• 00847536045163: COIL PV-6-20-3D V05
• 00847536045156: COIL PV-5-15-3D V05
• 00847536045149: COIL PV-4-12-3D V05
• 00847536045132: COIL PV-4-10-3D V05
• 00847536045125: COIL PV-3-8-3D V05
• 00847536045118: COIL PV-3-6-3D V05
• 00847536045101: COIL PV-3-4-3D V05
• 00847536045095: COIL PV-2-6-3D V05
• 00847536045088: COIL PV-2-4-3D V05
• 00847536045071: COIL PV-2-2-3D V05
• 00847536045064: COIL PV-20-50-HELIX V07
• 00847536045057: COIL PV-18-40-HELIX V07
• 00847536045040: COIL PV-16-40-HELIX V07
• 00847536045026: COIL PV-14-30-HELIX V07
• 00847536045002: COIL PV-12-30-HELIX V07
• 00763000307257: COIL PV-4-8-3D V05