Y-Needle 300

Y
LITe - DI_48850300

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.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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