Pipeline FA-77250-10

GUDID 00836462014084

Embolization Device

Covidien LP

Bare-metal intracranial vascular stent

• Primary Device ID: 00836462014084
• NIH Device Record Key: 444864fe-1316-4287-8dad-c1fd927ad973
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pipeline
• Version Model Number: FA-77250-10
• Catalog Number: FA-77250-10
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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

• Outer Diameter: 2.5 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462014084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100018

FDA Product Code

• OUT: Intracranial aneurysm flow diverter

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: 2014-09-22

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