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OnyxTM Liquid Embolic System (LES) 105-7100-040

by Micro Therapeutics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000765811 UDI-DI Date20 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
OnyxTM Liquid Embolic System (LES)
Generic Name
Neurovascular embolization plug
Model / Reference
105-7100-040
Primary DI / UDI-DI
00763000765811
PMA Number
FDA Product Code
SGU
GMDN Term
Neurovascular embolization plug
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (P030004)

Show all (12)

Other devices from Micro Therapeutics, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No