FDA.reportPublic FDA data

OptiMap™Catheter Extension Cable

Primary DI
00850064686081
Brand
OptiMap™Catheter Extension Cable
Company
Cortex, Inc.
Model
FG0004
Catalog number
OPTI-CEC
Device description
OptiMap™ Catheter Extension Cable
Published
2025-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850064686081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064686081008500646860818500646860810850064686081

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reprocessedA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a single-use device previously used that has been reprocessed for an additional single-use patient application.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
119228234
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850064686166OptiMap Catheter - 60mmOPTI-CATH2-602026-05-15
00850064686159OptiMap Catheter - 50mmOPTI-CATH2-502026-04-02
00850064686043OptiMap™ Cable Kit - NAFG0011-NAOPTI-CAB-NA2025-07-24
00850064686111OptiMap™ ECG Cables - NAFG0012-NAOPTI-ECG-NA2025-07-24
00850064686067OptiMap™ Catheter - 50mmFG0003-50OPTI-CATH-502025-07-24
00850064686104OptiMap™ Fiber Optic CableOPTI-FOCFG00062025-07-24
00850064686135OptiMap™ System - NAFG0001-NAOPTI-SYS-NA2025-07-24
00850064686074OptiMap™ Catheter - 60mmFG0003-60OPTI-CATH-602025-07-10
00850064686005OptiMap AmpliferFG0007OPTI-AMP2025-07-24
00850064686012OptiMap™ WorkstationFG0008OPTI-WS2025-07-24
00850064686029OptiMap MonitorFG0009OPTI-MON2025-07-24
00850064686036OptiMap CartFG0010OPTI-CART2025-07-24
00850064686098OptiMap™ System Interconnect CableFG0005OPTI-SIC2025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978035540010SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540027SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540034SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540041SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540058SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540065SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
00850087490122AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
00850087490146AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
06978035540003SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-05
00650551006602PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006619PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006626PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
04250307612871Adapter cable touchproof for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
04250307612888Connection cable for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
07613327688788N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-04-06
07613327643237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
07613327643244N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
03664539003559NADIXI MEDICALIKD2022-07-06
03664539003566NADIXI MEDICALIKD2022-07-06
03664539003573NADIXI MEDICALIKD2022-07-06
03664539003580NADIXI MEDICALIKD2022-07-06
03664539003603NADIXI MEDICALIKD2022-07-06
03664539003610NADIXI MEDICALIKD2022-07-06
03664539003627NADIXI MEDICALIKD2022-07-06
03664539003634NADIXI MEDICALIKD2022-07-06
08033695721525NAFIAB SPAIKD2021-07-08
08033695726278NAFIAB SPAIKD2020-06-13
08033695726995NAFIAB SPAIKD2020-06-13
08054242441734NAFIAB SPAIKD2020-06-13
08054953345864NAFIAB SPAIKD2020-06-13