ID-1-5

GUDID 00836462011045

Instant Detacher

Micro Therapeutics, Inc.

Embolization implant inserter Embolization implant inserter Embolization implant inserter Embolization implant inserter Embolization implant inserter Embolization implant inserter Embolization implant inserter Embolization implant inserter

• Primary Device ID: 00836462011045
• NIH Device Record Key: 92993d45-a768-435f-b0d5-ed21e498c436
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ID-1-5
• Catalog Number: ID-1-5
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, Inc.
• Device Count: 5
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462011045 [Primary]
GS1	10884521547063 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060747

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: 2015-10-22

Devices Manufactured by Micro Therapeutics, Inc.

• 00847536036215 - PipelineTM Vantage Embolization Device with Shield TechnologyTM: 2024-01-08 STENT PED3-021-250-10 V03 VANTAGE
• 00847536036222 - PipelineTM Vantage Embolization Device with Shield TechnologyTM: 2024-01-08 STENT PED3-021-250-12 V03 VANTAGE
• 00847536036239 - PipelineTM Vantage Embolization Device with Shield TechnologyTM: 2024-01-08 STENT PED3-021-250-14 V03 VANTAGE
• 00847536036246 - PipelineTM Vantage Embolization Device with Shield TechnologyTM: 2024-01-08 STENT PED3-021-250-16 V03 VANTAGE
• 00847536036253 - PipelineTM Vantage Embolization Device with Shield TechnologyTM: 2024-01-08 STENT PED3-021-250-18 V03 VANTAGE
• 00847536036260 - PipelineTM Vantage Embolization Device with Shield TechnologyTM: 2024-01-08 STENT PED3-021-250-20 V03 VANTAGE
• 00847536036277 - PipelineTM Vantage Embolization Device with Shield TechnologyTM: 2024-01-08 STENT PED3-021-275-10 V03 VANTAGE
• 00847536036284 - PipelineTM Vantage Embolization Device with Shield TechnologyTM: 2024-01-08 STENT PED3-021-275-12 V03 VANTAGE