Pipeline PED-475-10

GUDID 00836462015555

Flex Embolization Device

Micro Therapeutics, Inc.

Bare-metal intracranial vascular stent

• Primary Device ID: 00836462015555
• NIH Device Record Key: a2f5aaba-2842-4f3b-9576-99ca9aef098c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pipeline
• Version Model Number: PED-475-10
• Catalog Number: PED-475-10
• 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
• Length: 10 Millimeter
• Outer Diameter: 4.75 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Outer Diameter: 4.75 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Outer Diameter: 4.75 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Outer Diameter: 4.75 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Outer Diameter: 4.75 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Outer Diameter: 4.75 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Outer Diameter: 4.75 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Outer Diameter: 4.75 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Outer Diameter: 4.75 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Outer Diameter: 4.75 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Outer Diameter: 4.75 Millimeter
• Device Size Text, specify: 0

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	00836462015555 [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: 2015-02-13

On-Brand Devices [Pipeline]

• 00847536019782: PED-500-30 PIPELINE FLEX 5.00MM X 30MM
• 00847536019751: PED-500-25 PIPELINE FLEX 5.00MM X 25MM
• 00847536019720: PED-500-20 PIPELINE FLEX 5.00MM X 20MM
• 00847536019690: PED-500-18 PIPELINE FLEX 5.00MM X 18MM
• 00847536019669: PED-500-16 PIPELINE FLEX 5.00MM X 16MM
• 00847536019638: PED-500-14 PIPELINE FLEX 5.00MM X 14MM
• 00847536019584: FA-77450-10 PIPELINE EMB DEVICE
• 00847536019560: FA-77450-10 PIPELINE EMB DEVICE
• 00847536019522: FA-77425-20 PIPELINE EMB DEVICE
• 00847536019508: FA-77425-20 PIPELINE EMB DEVICE
• 00847536019461: FA-77425-18 PIPELINE EMB DEVICE
• 00847536019447: FA-77425-18 PIPELINE EMB DEVICE
• 00847536019409: FA-77425-16 PIPELINE EMB DEVICE
• 00847536019386: FA-77425-16 PIPELINE EMB DEVICE
• 00847536019348: FA-77425-14 PIPELINE EMB DEVICE
• 00847536019324: FA-77425-14 PIPELINE EMB DEVICE
• 00847536019287: FA-77425-12 PIPELINE EMB DEVICE
• 00847536019263: FA-77425-12 PIPELINE EMB DEVICE
• 00847536019225: FA-77425-10 PIPELINE EMB DEVICE
• 00847536019201: FA-77425-10 PIPELINE EMB DEVICE
• 00847536019164: FA-77400-20 PIPELINE EMB DEVICE
• 00847536019140: FA-77400-20 PIPELINE EMB DEVICE
• 00847536019102: FA-77400-18 PIPELINE EMB DEVICE
• 00847536019089: FA-77400-18 PIPELINE EMB DEVICE
• 00847536019041: FA-77400-16 PIPELINE EMB DEVICE
• 00847536019027: FA-77400-16 PIPELINE EMB DEVICE
• 00847536018983: FA-77400-14 PIPELINE EMB DEVICE
• 00847536018969: FA-77400-14 PIPELINE EMB DEVICE
• 00847536018921: FA-77400-12 PIPELINE EMB DEVICE
• 00847536018907: FA-77400-12 PIPELINE EMB DEVICE
• 00847536018860: FA-77400-10 PIPELINE EMB DEVICE
• 00847536018846: FA-77400-10 PIPELINE EMB DEVICE
• 00847536018815: FA-77500-10 PIPELINE EMB DEVICE
• 00847536016903: PED-500-35 PIPELINE FLEX 5.00MM X 35MM
• 00847536016897: PED-500-12 PIPELINE FLEX 5.00MM X 12MM
• 00847536016866: PED-500-10 PIPELINE FLEX 5.00MM X 10MM
• 00847536016835: PED-475-35 PIPELINE FLEX 4.75MM X 35MM
• 00847536016804: PED-475-30 PIPELINE FLEX 4.75MM X 30MM
• 00847536016774: PED-475-25 PIPELINE FLEX 4.75MM X 25MM
• 00847536016743: PED-475-20 PIPELINE FLEX 4.75MM X 20MM
• 00847536016712: PED-475-18 PIPELINE FLEX 4.75MM X 18MM
• 00847536016682: PED-475-16 PIPELINE FLEX 4.75MM X 16MM
• 00847536016651: PED-475-14 PIPELINE FLEX 4.75MM X 14MM
• 00847536016620: PED-475-12 PIPELINE FLEX 4.75MM X 12MM
• 00847536016590: PED-475-10 PIPELINE FLEX 4.75MM X 10MM
• 00847536016569: PED-450-35 PIPELINE FLEX 4.50MM X 35MM
• 00847536016538: PED-450-30 PIPELINE FLEX 4.50MM X 30MM
• 00847536016507: PED-450-25 PIPELINE FLEX 4.50MM X 25MM
• 00847536016477: PED-450-20 PIPELINE FLEX 4.50MM X 20MM
• 00847536016446: PED-450-18 PIPELINE FLEX 4.50MM X 18MM