FDA.reportPublic FDA data

Ponto

Primary DI
05712149000265
Brand
Ponto
Company
Oticon Medical AB
Model
M50098
Catalog number
M50098
Device description
Cover screw hexagon
Published
2015-09-10
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
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712149000265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712149000265057121490002655712149000265

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
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
05712149008858PontoM52080M520802016-09-16

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