NXT N-3-10-T10

GUDID 00836462017443

Detachable Coil

Micro Therapeutics, Inc.

Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil

• Primary Device ID: 00836462017443
• NIH Device Record Key: 9d18dbdf-ef40-4955-bf7f-396360f4f214
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NXT
• Version Model Number: N-3-10-T10
• Catalog Number: N-3-10-T10
• 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: 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: 3.3 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462017443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041649

FDA Product Code

• HCG: DEVICE, NEUROVASCULAR 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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