System Cable

System Cable - MAJ-202

A 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 reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: ODA

Device Name: Endoscopic Central Control Unit

Device Class: 2

Physical State: may include: monitor, remote (or other wireless device), microphone, card adaptor, cables, other hardware and software

Definition: To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Connect operating systems into central control unit

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: endoscopic and other ancillary surgical equipment

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170144929

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A