MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4

MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES
MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 - UCES-4

A mains electricity (AC-powered) device assembly designed to provide operating room (OR) staff with a single point of management to operate electromechanical/electronic medical devices of different makes during surgery. It is a computer-based integrated hardware/software application that typically consists of a base unit (outside the sterile field or the OR) to which all device cabling is connected, and software that runs on an off-the-shelf computer with a touchscreen (in the OR). The system is intended to manipulate devices such as OR lights, OR tables, cameras, video endoscope images, and monitors; it may also be used to manage patient data from these devices.

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

Code: GCJ

Device Name: Laparoscope, General & Plastic Surgery

Device Class: 2

Physical State: N/A

Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170391767

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