Ponto

Basic Information

• Brand Name: Ponto
• Primary DI: 05712149011889
• Version / Model: M52654
• Catalog Number: M52654
• Company Name: Oticon Medical AB
• Labeler DUNS: 554563994
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-11
• Public Version: 4
• Public Version Date: 2022-12-05
• Public Version Status: Update
• Public Device Record Key: be3ab9ff-0ff6-4d51-8c19-ffb4532a3e22

Device Description

Ponto 3 SuperPower, L, WHS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	874.3302	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34180	Anchored bone-conduction hearing implant system	A sterile, battery-powered, electromechanical device assembly intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, through the skull to the inner ear. It typically consists of a self-contained microphone, amplifier, and vibrator mounted on a titanium (Ti) post which is implanted into the skull, typically the mastoid bone, and protrudes through the skin. Sound waves are converted into electrical signals and sent to the vibrator, which transmits vibrations directly through bone to the inner ears for hearing. It is used to treat hearing impairment due to middle and/or outer ear obstructive pathologies or types of conductive hearing loss.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05712149011889	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]