Y
LITe - DI_48850300
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
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PDQ
Device Name: Neurosurgical Nerve Locator
Device Class: 2
Physical State: A user interface/control unit; handpiece with tip to deliver the electric current; and a separate monitoring electrode if detection is not built in the same tip.
Definition: To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Submission Type ID: 1
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Sends out electrical current, monitors for this current, and informs user of a change from baseline.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Spinal nerve roots or peripheral nerves
Regulation Number: 874.1820
Third Party Flag: N
Medical Specialty: EN
Device IdentifiersDevice Id: 07613327359589
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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