NXT N-5-10-T10-TC

GUDID 00836462019232

Detachable Coil

Micro Therapeutics, Inc.

Neurovascular embolization coil

• Primary Device ID: 00836462019232
• NIH Device Record Key: 61f62cad-260b-4e25-badc-a6255185be9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NXT
• Version Model Number: N-5-10-T10-TC
• Catalog Number: N-5-10-T10-TC
• 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
• Length: 10 Centimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 5 Millimeter
• 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	00836462019232 [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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