RACETRACK S0394

RACETRACK S0394
NA - S0394

A device intended to be fixed/worn on a patient’s head to hold a head-worn bone-conduction hearing aid. It may be adhered to the skin, magnetically held in place on the side of the head by an implantable magnet (not included), attached to existing clothing (e.g., hat) or worn like a headband. It may include dedicated devices (e.g., scale) used in the fitting process. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LXB

Device Name: Hearing Aid, Bone Conduction

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: EN

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: 874.3302

Third Party Flag: Y

Medical Specialty: EN

Device Id: 00643169719767

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