OnyxTM Liquid Embolic System (LES)

Basic Information

• Brand Name: OnyxTM Liquid Embolic System (LES)
• Primary DI: 00763000925338
• Version / Model: 105-7100-060
• Company Name: Micro Therapeutics, Inc.
• Labeler DUNS: 826110710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-02
• Public Version: 1
• Public Version Date: 2026-01-12
• Public Version Status: New
• Public Device Record Key: 330e352e-1468-4c53-bb9e-003c7ab5fd45

Device Description

LIQUID EMBOLIC 105-7100-060 V08

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MFE	Agent, injectable, embolic	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60939	Neurovascular embolization plug	A non-bioabsorbable material (e.g., gel, liquid) intended to be implanted in a neurovascular blood vessel, to obstruct blood flow to treat a brain arteriovenous malformation (bAVM). It may be supplied as a liquid [e.g., ethylene vinyl alcohol (EVOH)], gel or powder intended to solidify or expand in situ to create a barrier to blood flow (embolus); it contains no pharmaceutical agents. It may be supplied with dedicated instruments for implantation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000925338	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P030004	035

Storage Conditions

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