MAGNETIC IMPLANT S0263-01 MRI COND

MAGNETIC IMPLANT S0263
Otomag™ Alpha (M) Magnetic Implant - S0263-01

A sterile implantable magnetized device intended to be used to magnetically hold in place a head-worn bone-conduction hearing aid (against the skin on the side of the head), usually using a base plate. It is metallic, typically flat-disc- or dual-disc-shaped, and permanently implanted with screws in the mastoid process or parietal bone of the skull. Disposable devices associated with implantation may be included.

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

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: 00643169645318

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