FDA.reportPublic FDA data

Ponto

Primary DI
05712149009664
Brand
Ponto
Company
Oticon Medical AB
Model
M52173
Catalog number
M52173
Device description
Ponto BHX Implant, 4 mm
Published
2015-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712149009664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712149009664057121490096645712149009664

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Contacts#

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

Regulatory Flags#

DUNS number
554563994
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
05712149026302PontoOticon Medical ABMAH2021-03-31
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