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OptiMap Catheter - 60mm OPTI-CATH2-60

by Cortex, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850064686166 UDI-DI Date15 May 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  • Withdrawn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
OptiMap Catheter - 60mm
Generic Name
Cardiac mapping catheter, percutaneous, single-use
Model / Reference
OPTI-CATH2-60
Primary DI / UDI-DI
00850064686166
FDA Product Code
MTD
GMDN Term
Cardiac mapping catheter, percutaneous, single-use
Device Class
Class II
Regulation Number
870.1220
GUDID distribution status
In Commercial Distribution

Other devices from Cortex, Inc.

See all devices from Cortex, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

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