Onyx HD 500

GUDID 00836462005129

105-8101-500 ONYX HD500 KIT ANEURYS

Micro Therapeutics, Inc.

Neurovascular embolization plug

• Primary Device ID: 00836462005129
• NIH Device Record Key: 19a1c04f-752b-4dc9-b160-653ae26d6e6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Onyx HD 500
• Version Model Number: 105-8101-500
• 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: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 19 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 19 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 19 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 19 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 19 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 19 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 19 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 19 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 19 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 19 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 19 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 19 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462005129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H060003

FDA Product Code

• OBA: Polymerizing, neurovascular embolization material

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2014-09-22

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