AccessGUDID - DEVICE: OnyxTM Liquid Embolic System (LES) (00763000925352)

GUDID

Device Identifier (DI) Information

Brand Name: OnyxTM Liquid Embolic System (LES)
Version or Model: 105-7100-080
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro Therapeutics, Inc.

Primary DI Number: 00763000925352
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 826110710 *Terms of Use

Device Description: LIQUID EMBOLIC 105-7100-080 V08

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MFE	Agent, injectable, embolic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P030004	035

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 32991b0b-2a30-4516-ba41-54329fa0b441
Public Version Date: January 12, 2026
Public Version Number: 1
DI Record Publish Date: January 02, 2026