ID-1-5

GUDID 00836462011045

Instant Detacher

Micro Therapeutics, Inc.

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.

• 00763000845315 - Axium™ Detachable Coil System: 2025-01-06 COIL QC-1.5-1-HELIX V14
• 00763000845322 - Axium™ Detachable Coil System: 2025-01-06 COIL QC-1.5-2-HELIX V14
• 00763000845339 - Axium™ Detachable Coil System: 2025-01-06 COIL QC-1.5-3-HELIX V14
• 00763000845346 - Axium™ Detachable Coil System: 2025-01-06 COIL QC-1.5-4-HELIX V14
• 00763000845353 - Axium™ Detachable Coil System: 2025-01-06 COIL QC-2-1-HELIX V14
• 00763000845360 - Axium™ Detachable Coil System: 2025-01-06 COIL QC-2-2-HELIX V14
• 00763000845377 - Axium™ Detachable Coil System: 2025-01-06 COIL QC-2-3-HELIX V14
• 00763000845384 - Axium™ Detachable Coil System: 2025-01-06 COIL QC-2-4-HELIX V14