BASE PLATE S0266
ATTRACT™ - S0266-06
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 00643169719606
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