OnyxTM Liquid Embolic System (LES)

GUDID 00763000925338

LIQUID EMBOLIC 105-7100-060 V08

Micro Therapeutics, Inc.

Neurovascular embolization plug

• Primary Device ID: 00763000925338
• NIH Device Record Key: 330e352e-1468-4c53-bb9e-003c7ab5fd45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OnyxTM Liquid Embolic System (LES)
• Version Model Number: 105-7100-060
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Prior to use, maintain product temperature between 19 °C (66.2°F) and 24°C (75.2°F).
• Special Storage Condition, Specify: Between 0 and 0 *If product freezes due to exposure to colder temperatures, thaw at room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Prior to use, maintain product temperature between 19 °C (66.2°F) and 24°C (75.2°F).
• Special Storage Condition, Specify: Between 0 and 0 *If product freezes due to exposure to colder temperatures, thaw at room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Prior to use, maintain product temperature between 19 °C (66.2°F) and 24°C (75.2°F).
• Special Storage Condition, Specify: Between 0 and 0 *If product freezes due to exposure to colder temperatures, thaw at room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Prior to use, maintain product temperature between 19 °C (66.2°F) and 24°C (75.2°F).
• Special Storage Condition, Specify: Between 0 and 0 *If product freezes due to exposure to colder temperatures, thaw at room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Prior to use, maintain product temperature between 19 °C (66.2°F) and 24°C (75.2°F).
• Special Storage Condition, Specify: Between 0 and 0 *If product freezes due to exposure to colder temperatures, thaw at room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Prior to use, maintain product temperature between 19 °C (66.2°F) and 24°C (75.2°F).
• Special Storage Condition, Specify: Between 0 and 0 *If product freezes due to exposure to colder temperatures, thaw at room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Prior to use, maintain product temperature between 19 °C (66.2°F) and 24°C (75.2°F).
• Special Storage Condition, Specify: Between 0 and 0 *If product freezes due to exposure to colder temperatures, thaw at room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Prior to use, maintain product temperature between 19 °C (66.2°F) and 24°C (75.2°F).
• Special Storage Condition, Specify: Between 0 and 0 *If product freezes due to exposure to colder temperatures, thaw at room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Prior to use, maintain product temperature between 19 °C (66.2°F) and 24°C (75.2°F).
• Special Storage Condition, Specify: Between 0 and 0 *If product freezes due to exposure to colder temperatures, thaw at room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Prior to use, maintain product temperature between 19 °C (66.2°F) and 24°C (75.2°F).
• Special Storage Condition, Specify: Between 0 and 0 *If product freezes due to exposure to colder temperatures, thaw at room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Prior to use, maintain product temperature between 19 °C (66.2°F) and 24°C (75.2°F).
• Special Storage Condition, Specify: Between 0 and 0 *If product freezes due to exposure to colder temperatures, thaw at room temperature before use.
• Special Storage Condition, Specify: Between 0 and 0 *Device should be stored in a dry place, away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000925338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030004

FDA Product Code

• MFE: Agent, injectable, embolic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-12
• Device Publish Date: 2026-01-02

On-Brand Devices [OnyxTM Liquid Embolic System (LES)]

• 00763000925352: LIQUID EMBOLIC 105-7100-080 V08
• 00763000925338: LIQUID EMBOLIC 105-7100-060 V08