NXT N-2-6-T10-F

GUDID 00836462017375

Detachable Coil

Micro Therapeutics, Inc.

Neurovascular embolization coil

• Primary Device ID: 00836462017375
• NIH Device Record Key: dca9c829-2962-485d-a435-62c453003d2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NXT
• Version Model Number: N-2-6-T10-F
• Catalog Number: N-2-6-T10-F
• 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: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 3.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 3.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 3.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 3.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 3.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 3.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 3.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 3.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 3.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 3.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2 Millimeter
• Length: 6 Centimeter
• Outer Diameter: 3.1 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	00836462017375 [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

On-Brand Devices [NXT]

• 00836462019263: Detachable Coil
• 00836462019256: Detachable Coil
• 00836462019249: Detachable Coil
• 00836462019232: Detachable Coil
• 00836462019225: Detachable Coil
• 00836462019218: Detachable Coil
• 00836462019201: Detachable Coil
• 00836462019195: Detachable Coil
• 00836462019188: Detachable Coil
• 00836462019171: Detachable Coil
• 00836462019126: Detachable Coil
• 00836462019119: Detachable Coil
• 00836462018112: Detachable Coil
• 00836462018105: Detachable Coil
• 00836462018099: Detachable Coil
• 00836462018082: Detachable Coil
• 00836462018075: Detachable Coil
• 00836462018068: Detachable Coil
• 00836462018051: Detachable Coil
• 00836462018044: Detachable Coil
• 00836462018037: Detachable Coil
• 00836462018020: Detachable Coil
• 00836462018013: Detachable Coil
• 00836462018006: Detachable Coil
• 00836462017993: Detachable Coil
• 00836462017986: Detachable Coil
• 00836462017979: Detachable Coil
• 00836462017962: Detachable Coil
• 00836462017597: Detachable Coil
• 00836462017580: Detachable Coil
• 00836462017573: Detachable Coil
• 00836462017566: Detachable Coil
• 00836462017559: Detachable Coil
• 00836462017542: Detachable Coil
• 00836462017535: Detachable Coil
• 00836462017528: Detachable Coil
• 00836462017511: Detachable Coil
• 00836462017504: Detachable Coil
• 00836462017498: Detachable Coil
• 00836462017481: Detachable Coil
• 00836462017474: Detachable Coil
• 00836462017467: Detachable Coil
• 00836462017450: Detachable Coil
• 00836462017443: Detachable Coil
• 00836462017436: Detachable Coil
• 00836462017429: Detachable Coil
• 00836462017412: Detachable Coil
• 00836462017405: Detachable Coil
• 00836462017399: Detachable Coil
• 00836462017382: Detachable Coil