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OptiMap™ System - NA FG0001-NA

by Cortex, Inc.

OptiMap™ System - NA FG0001-NA (OPTI-SYS-NA) is a Class II device made by Cortex, Inc., listed in FDA GUDID since 24 Jul 2025 (UDI-DI 00850064686135), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850064686135 UDI-DI Date24 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
OptiMap™ System - NA
Generic name
Cardiac mapping system
Model / Ref / Catalog
FG0001-NA, OPTI-SYS-NA
Primary DI / UDI-DI
00850064686135
FDA product code
DQK
GMDN term
Cardiac mapping system
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac mapping system

Similar devices in this category

Other devices filed under Cardiac mapping system.

Other devices from Cortex, Inc.

See all devices from Cortex, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)