TI6 LOW PROFILE 2.0MM X 16MM BONE SCREW

TI6 LOW PROFILE 2.0MM X 16MM BONE SCREW
Ti6 Internal Fixation System - TC2016

An electrically-powered wearable device intended to apply vibroacoustic therapy (VAT) stimuli to the head to treat stress and sleep disorder symptoms (e.g., insomnia, migraine, anxiety) by inducing a state of brain relaxation. It is typically in the form of a headband to be positioned over the forehead and temporal areas of the head, and includes dedicated software for vibration frequency programming from a wirelessly connected smart device (not included). It is intended to be used in clinical and home settings.

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: HWC

Device Name: Screw, Fixation, Bone

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3040

Third Party Flag: N

Medical Specialty: OR

Device Id: 00885556835609

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