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Embrace Hydrogel Embolic System (HES) INS90-4001-003

by Instylla, 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 Number00812013030215 UDI-DI Date1 Dec 2025ListedStatusListed 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  • Withdrawn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
Embrace Hydrogel Embolic System (HES)
Generic Name
Non-neurovascular embolization plug, synthetic polymer, bioabsorbable
Model / Reference
INS90-4001-003
Primary DI / UDI-DI
00812013030215
PMA Number
FDA Product Code
QVG
GMDN Term
Non-neurovascular embolization plug, synthetic polymer, bioabsorbable
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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