MAJ-1939 SMOKE EVACUATION FOOT SWITCH


Product Overview

MAJ
SMOKE EVACUATION FOOT SWITCH - MAJ-1939


Device Description

An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable 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: HIF

Device Name: Insufflator, Laparoscopic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OB

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: 884.1730

Third Party Flag: N

Medical Specialty: OB


Code: OSV

Device Name: Insufflator, Endoscopic Vessel Harvesting

Device Class: 2

Physical State: An electronic software controlled gas insufflator which can accept CO2 gas from either a tank or central wall supply. The gas flow rate and pressure can be adjusted by the user.

Definition: To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.

Submission Type ID: 1

Review Panel: OB

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The insufflator delivers CO2 gas at a controlled flow rate and pressure to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Leg, saphenous vein or arm, radial artery

Regulation Number: 884.1730

Third Party Flag: N

Medical Specialty: OB


Device Identifiers

Device Id: 04953170324185

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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