FDA.reportPublic FDA data

OptiMap™ Fiber Optic Cable

Primary DI
00850064686104
Brand
OptiMap™ Fiber Optic Cable
Company
Cortex, Inc.
Model
OPTI-FOC
Catalog number
FG0006
Device description
OptiMap™ Fiber Optic Cable
Published
2025-07-24
Public version status
Update
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
00850064686104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064686104008500646861048500646861040850064686104

GMDN Terms#

Term, Definition table
TermDefinition
Sensor catheter fibreoptic connection cableA fibreoptic cord designed for bidirectional transmission of light between a patient monitor and a sensor catheter (e.g., intracerebral sensor catheter). It is typically used for transmitting light used to measure intracerebral partial pressure of oxygen (pO2) (e.g., during an oxygen-driven fluorescence quenching reaction). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119228234
Device count
1
Premarket exempt
true
Lot or batch
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
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
00850064686081OptiMap™Catheter Extension CableFG0004OPTI-CEC2025-07-24

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