Digital Video Processor, Input Voltage: 5V 2A (for use with Dornier Ureteroscope)

Digital Video Processor, Input Voltage: 5V 2A (for use with Dornier Ureteroscope)
Dornier MedTech - Axis Video Processor

An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FGB

Device Name: Ureteroscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, associated accessories

Definition: To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (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: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Inserted into blood urinary tract through urethra

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: urinary tract

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 00810116020713

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