FDA.reportPublic FDA data

Ponto

Primary DI
05712149026524
Brand
Ponto
Company
Oticon Medical AB
Model
223164
Catalog number
223164
Device description
PONTO 5 SUPERPOWER, CNB
Published
2022-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXBHearing Aid, Bone Conduction
MAHHearing Aid, Bone Conduction, Implanted

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213733000Ponto 5 SuperPowerOticon Medical AB2021-12-16LXB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712149026524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712149026524057121490265245712149026524

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
05712149000265PontoM50098M500982015-09-10
05712149000326PontoM50287M502872016-09-16
05712149000562PontoM50384M503842016-09-16
05712149000586PontoM50386M503862016-09-16
05712149000647PontoM50428M504282016-09-16
05712149000654PontoM50437M504372016-09-16
05712149001026PontoM50534M505342016-09-16
05712149005888PontoM51690M516902016-09-16
05712149005895PontoM51695M516952016-09-16
05712149025350Ponto1867771867772019-06-03
05712149025367Ponto1867781867782019-06-03
05712149025374Ponto1867791867792019-06-03
05712149025381Ponto1867801867802019-06-03
05712149025398Ponto186781M526502019-06-03
05712149025404Ponto1867821867822019-06-03
05712149025411Ponto2013862013862019-06-03
05712149000289PontoM50104M501042016-09-09
05712149000395PontoM50308M503082016-09-09
05712149003808PontoM51122M511222016-09-16
05712149003983PontoM51144M511442016-09-16

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
05712149027453PontoOticon Medical ABLXB2023-08-21
05712149027460PontoOticon Medical ABLXB2023-08-21
05712149027477PontoOticon Medical ABLXB2023-08-21
05712149027484PontoOticon Medical ABLXB2023-08-21
05712149027491PontoOticon Medical ABLXB2023-08-21
05712149027507PontoOticon Medical ABLXB2023-08-21
05712149027514PontoOticon Medical ABLXB2023-08-21
05712149027521PontoOticon Medical ABLXB2023-08-21
05712149026562PontoOticon Medical ABLXB2022-09-17
05712149026579PontoOticon Medical ABLXB2022-09-17
05712149026586PontoOticon Medical ABLXB2022-09-17
05712149026593PontoOticon Medical ABLXB2022-09-17
05712149026609PontoOticon Medical ABLXB2022-09-17
05712149026616PontoOticon Medical ABLXB2022-09-17
05712149026623PontoOticon Medical ABLXB2022-09-17
05712149026630PontoOticon Medical ABLXB2022-09-17
05712149026722PontoOticon Medical ABLXB2022-09-17
05712149026739PontoOticon Medical ABLXB2022-09-17