- Physicians Office Resource

Monopolar Probe 45mm, angled 30 degree
NA - 5140-525-603

Device Description

A hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device.

Environmental Conditions

Storage Environment Humidity - Percent (%) Relative Humidity

85.00
30.00

Storage Environment Temperature - Degrees Celsius

35.00
4.00

Device Sizes

Angle: 30.0 degree

Length: 45.0 Millimeter

Angle: 30.0 degree
Length: 45.0 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: GWF

Device Name: Stimulator, Electrical, Evoked Response

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: NE

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: 882.1870

Third Party Flag: Y

Medical Specialty: NE

Device Identifiers

Device Id: 37613327282215

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07613327282214

Package Quantity: 10

Package Discontinue Date: 12/31/2020 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: pack

Device Id: 07613327282214

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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