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Nitinol Enhanced Device N3F-2300

by Embolization, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number10857798005130 UDI-DI Date12 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Nitinol Enhanced Device
Generic Name
Non-neurovascular embolization coil
Model / Ref / Catalog
N3F-2300
Primary DI / UDI-DI
10857798005130
FDA Product Code
KRD
GMDN Term
Non-neurovascular embolization coil
Device Class
Class II
Regulation Number
870.3300
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Other devices from Embolization, Inc.

Properties

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

Other properties (7)

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