ENDO
ENDO-GATOR - EGP-100P
Device Description
A sterile, hand-operated surgical device intended for the controlled delivery of medical gas and fluid (e.g., saline solution) to an open surgical site to improve visibility, by clearing bloody fluids/debris, and to prevent tissue desiccation. It is typically made of plastic materials [e.g., polypropylene, polyvinyl chloride (PVC)] and may be double-lumen for nebulization of fluid/gas, or dual-line for separate fluid and gas administration and include an antibacterial filter. It typically includes a nozzle at the distal end and connector(s) [e.g., Luer] at the proximal end for connection to the fluid/gas sources; a manual tubing clamp may also be included. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OCX
Device Name: Endoscopic Irrigation/Suction System
Device Class: 2
Physical State: may include: pump, motor, tubing, controller, air switch, power supply, transducer, digital display, suction attachment, bottle cap
Definition: To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Connects to tubing from pump and goes down working channel of endoscope
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: endoscope
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 04961333243037
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
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