CONCERTO PV-20-50-HELIX

GUDID 00836462013315

Detachable Coil System

Micro Therapeutics, Inc.

Non-neurovascular embolization coil

• Primary Device ID: 00836462013315
• NIH Device Record Key: af4b0e87-6f5a-439c-8cb1-6c445c11a302
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONCERTO
• Version Model Number: PV-20-50-HELIX
• Catalog Number: PV-20-50-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: true
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 50 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 20 Millimeter
• Length: 50 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462013315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090046

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-16

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• 00836462013391: Detachable Coil System
• 00836462013384: Detachable Coil System
• 00836462013377: Detachable Coil System
• 00836462013360: Detachable Coil System
• 00836462013353: Detachable Coil System
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• 00836462013339: Detachable Coil System
• 00836462013322: Detachable Coil System
• 00836462013315: Detachable Coil System
• 00836462013308: Detachable Coil System
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• 00836462013285: DETACHABLE COIL SYSTEM
• 00836462013278: Detachable Coil System
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• 00836462012790: Detachable Coil System
• 00836462012783: Detachable Coil System
• 00836462011465: Detachable Coil System
• 00836462011441: Detachable Coil System
• 00836462011434: Detachable Coil System
• 00836462011410: Detachable Coil System
• 00836462011403: Detachable Coil System