FDA.reportPublic FDA data

Ponto

Primary DI
05712149026302
Brand
Ponto
Company
Oticon Medical AB
Model
220701
Catalog number
220701
Device description
MONO Surgery Kit
Published
2021-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203807000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203807000Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical AB2021-03-03MAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712149026302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712149026302057121490263025712149026302

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
554563994
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
05712149026494PontoOticon Medical ABMAH2022-04-01
05712149026500PontoOticon Medical ABMAH2022-04-01
05712149026517PontoOticon Medical ABMAH2022-04-01
05712149026524PontoOticon Medical ABMAH2022-04-01
05712149026531PontoOticon Medical ABMAH2022-04-01
05712149026548PontoOticon Medical ABMAH2022-04-01
05712149026555PontoOticon Medical ABMAH2022-04-01
05712149026319PontoOticon Medical ABMAH2021-09-01
05712149026432PontoOticon Medical ABMAH2021-09-01
05712149026449PontoOticon Medical ABMAH2021-09-01
05712149026456PontoOticon Medical ABMAH2021-09-01
05712149026463PontoOticon Medical ABMAH2021-09-01
05712149026470PontoOticon Medical ABMAH2021-09-01
05712149026487PontoOticon Medical ABMAH2021-09-01
09321502043847BahaCochlear Bone Anchored Solutions ABMAH2020-01-25
09321502043854BahaCochlear Bone Anchored Solutions ABMAH2020-01-25
09321502043892BIA310 Implant 4mm with 6mm abutmentCochlear Bone Anchored Solutions ABMAH2019-05-22
09321502043908BIA310 Implant 4 mm with 14mm abutmentCochlear Bone Anchored Solutions ABMAH2019-05-22
09321502043861BahaCochlear Bone Anchored Solutions ABMAH2019-05-16
09321502043878BahaCochlear Bone Anchored Solutions ABMAH2019-05-16
09321502043885BahaCochlear Bone Anchored Solutions ABMAH2019-05-16
09321502043915BIA310 Implant 4mm with 12mm abutmentCochlear Bone Anchored Solutions ABMAH2019-05-16
09321502043922BIA310 Implant 4mm with 10mm abutmentCochlear Bone Anchored Solutions ABMAH2019-05-16
09321502043939BIA310 Implant 4mm with 8mm abutmentCochlear Bone Anchored Solutions ABMAH2019-05-16
05712149025091PontoOticon Medical ABMAH2018-10-24
05712149025107PontoOticon Medical ABMAH2018-10-24
05712149000326PontoOticon Medical ABMAH2016-09-16
05712149000562PontoOticon Medical ABMAH2016-09-16
05712149000586PontoOticon Medical ABMAH2016-09-16
05712149000647PontoOticon Medical ABMAH2016-09-16