CONCERTO VERSA™

GUDID 00763000321680

Coil CV-12-50 Concerto Versa V02

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

• Primary Device ID: 00763000321680
• NIH Device Record Key: a1f5ca95-18d9-4b77-819e-bf42c493e799
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONCERTO VERSA™
• Version Model Number: CV-12-50
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place and away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000321680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202850

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: 2021-03-12
• Device Publish Date: 2021-03-04

On-Brand Devices [CONCERTO VERSA™]

• 00763000322106: Coil CV-32-65 Concerto Versa V02
• 00763000322076: Coil CV-32-40 Concerto Versa V02
• 00763000322045: Coil CV-28-65 Concerto Versa V02
• 00763000322014: Coil CV-28-40 Concerto Versa V02
• 00763000321987: Coil CV-24-65 Concerto Versa V02
• 00763000321956: Coil CV-24-40 Concerto Versa V02
• 00763000321925: Coil CV-20-65 Concerto Versa V02
• 00763000321895: Coil CV-20-40 Concerto Versa V02
• 00763000321864: Coil CV-18-65 Concerto Versa V02
• 00763000321833: Coil CV-18-40 Concerto Versa V02
• 00763000321802: Coil CV-16-65 Concerto Versa V02
• 00763000321772: Coil CV-16-40 Concerto Versa V02
• 00763000321741: Coil CV-14-65 Concerto Versa V02
• 00763000321710: Coil CV-14-40 Concerto Versa V02
• 00763000321680: Coil CV-12-50 Concerto Versa V02
• 00763000321659: Coil CV-12-30 Concerto Versa V02
• 00763000321628: Coil CV-10-40 Concerto Versa V02
• 00763000321598: Coil CV-10-20 Concerto Versa V02
• 00763000321567: Coil CV-9-40 Concerto Versa V02
• 00763000321536: Coil CV-9-20 Concerto Versa V02
• 00763000321505: Coil CV-8-40 Concerto Versa V02
• 00763000321475: Coil CV-8-20 Concerto Versa V02
• 00763000321444: Coil CV-7-40 Concerto Versa V02
• 00763000321413: Coil CV-7-20 Concerto Versa V02
• 00763000321383: Coil CV-6-40 Concerto Versa V02
• 00763000321352: Coil CV-6-20 Concerto Versa V02
• 00763000321321: Coil CV-5-30 Concerto Versa V02
• 00763000321291: Coil CV-5-20 Concerto Versa V02
• 00763000321260: Coil CV-4-15 Concerto Versa V02
• 00763000321239: Coil CV-4-5 Concerto Versa V02
• 00763000321208: Coil CV-3-15 Concerto Versa V02
• 00763000321178: Coil CV-3-5 Concerto Versa V02