- Physicians Office Resource

IGS WF BP - NA

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: IZI

Device Name: System, X-Ray, Angiographic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

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: 892.1600

Third Party Flag: N

Medical Specialty: RA

Code: OWB

Device Name: Interventional Fluoroscopic X-Ray System

Device Class: 2

Physical State: Fluoroscopic X-Ray system

Definition: Interventional fluoroscopy

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Fluoroscopy

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human body

Regulation Number: 892.1650

Third Party Flag: Y

Medical Specialty: RA

Code: JAA

Device Name: System, X-Ray, Fluoroscopic, Image-Intensified

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

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: 892.1650

Third Party Flag: Y

Medical Specialty: RA

Code: OXO

Device Name: Image-Intensified Fluoroscopic X-Ray System, Mobile

Device Class: 2

Physical State: Hardware

Definition: Fluoroscopy of the human body.

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: X-ray transmission through human body

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human Body

Regulation Number: 892.1650

Third Party Flag: Y

Medical Specialty: RA

Device Identifiers

Device Id: 00840682141284

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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