FDA.reportPublic FDA data

Ponto

Primary DI
05712149008858
Brand
Ponto
Company
Oticon Medical AB
Model
M52080
Catalog number
M52080
Device description
Soft healing cap
Published
2016-09-16
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712149008858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712149008858057121490088585712149008858

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-supportive tube/strip, single-useAn elastic device intended to be worn over/around a limb (arm/leg) and/or finger to cover and support a dressing on a wound/injury (e.g., burn, postoperative, skin condition). It may be referred to as a dressing/bandage retainer and is either in the form of a generic tube (i.e., not a specific garment such as a sock, glove, vest, shorts, or hat) or gripping elastic strip made of synthetic material (e.g., nylon/elastane), and is available in various sizes for daily use in the home or healthcare facility. It may additionally be intended for use at other anatomical sites (where size is appropriate) however it is not dedicated to the abdomen/thorax. 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
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
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