FDA.reportPublic FDA data

Ponto

Primary DI
05712149000159
Brand
Ponto
Company
Oticon Medical AB
Model
130-00-222-00
Catalog number
130-00-222-00
Device description
Ponto Pro, right, diamond black
Published
2016-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXBHearing Aid, Bone Conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXBHearing Aid, Bone ConductionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712149000159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712149000159057121490001595712149000159

GMDN Terms#

Term, Definition table
TermDefinition
Anchored bone-conduction hearing implant systemA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-277-8014info@oticonmedical.com

Regulatory Flags#

DUNS number
554563994
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05712149027743Ponto Instant2846482846482026-05-21
05712149025459Sentio2053382053382024-07-22
05712149025466Sentio2053392053392024-07-22
05712149025473Sentio2053402053402024-07-22
05712149025480Sentio2053412053412024-07-22
05712149025497Sentio2053422053422024-07-22
05712149025503Sentio2053432053432024-07-22
05712149026906Sentio1863231863232024-07-22
05712149008865Oticon MedicalM52143M521432016-09-16
05712149027590Genie Medical2752032752032024-08-08
05712149027637Genie Medical2752092752092024-08-08
05712149027644Genie Medical2753512753512024-08-08
05712149027408Screwdriver HexaDrive2654972654972024-06-14
05712149000265PontoM50098M500982015-09-10
05712149000296PontoM50220M502202015-09-10
05712149000425PontoM50318M503182015-09-10
05712149000432PontoM50319M503192015-09-10
05712149000470PontoM50349M503492015-09-10
05712149000494PontoM50358M503582015-09-10
05712149000500PontoM50362M503622015-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05712149027743Ponto InstantOticon Medical ABLXB2026-05-21
09120041056673contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056697contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056703contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056710contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056727contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056734contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056741contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056758contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056765contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056772contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056895HearbowBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041050145contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041050176contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041050190contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041050220contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041051852contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041051906contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052149contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052156contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052163contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052309contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052316contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052323contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059575contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059582contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059599contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059605contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059612contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059650contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17