TOUCH PANEL FOR ENDOALPHA

TOUCH PANEL FOR ENDOALPHA - MAJ-1828

An electrically-powered visual display unit (VDU) designed as an output device for displaying data (e.g., patient images, videos) and as an input device to enable interactive manipulation of the data by the operator through touches to the display screen. It is intended to be connected to a computer or a medical device (i.e., the screen has no computing capabilities); it may be used to control a medical device (e.g., operating room lights) depending on parent device software. It is typically a portable or mounted liquid crystal display (LCD) or light-emitting diode (LED) unit, and may include an antimicrobial material to prevent cross-contamination in a medical setting.

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: 04953170291470

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