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

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

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
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
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