FDA.reportPublic FDA data

Oticon

Primary DI
05707131336675
Brand
Oticon
Company
Oticon A/S
Model
188313
Device description
FM REC, AMIGO R12G2 169-187 MHZ C091
Published
2018-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707131336675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707131336675057071313366755707131336675

GMDN Terms#

Term, Definition table
TermDefinition
Hearing device remote controlA battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4539177100hama@oticon.com

Regulatory Flags#

DUNS number
305839946
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05707131329868Oticon1789432018-08-20
05707131329882Oticon1789452018-08-20
05707131329899Oticon1789462018-08-20
05707131329912Oticon1789482018-08-20
05707131331496Oticon1825732018-08-20
05707131331519Oticon1825752018-08-20
05707131331526Oticon1825762018-08-20
05707131331540Oticon1825782018-08-20
05707131331694Oticon1827252018-08-20
05707131331717Oticon1827272018-08-20
05707131331724Oticon1827282018-08-20
05707131331748Oticon1827302018-08-20
05707131339911Oticon1919072018-08-20
05707131339935Oticon1919092018-08-20
05707131339942Oticon1919102018-08-20
05707131339966Oticon1919122018-08-20
05707131340375Oticon1919402018-08-20
05707131340399Oticon1919422018-08-20
05707131340405Oticon1919432018-08-20
05707131340429Oticon1919452018-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296253166GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253173GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253180GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253197GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253203GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253210GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253227GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253234GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253241GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257966GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257973GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257980GN ReSoundGn Hearing A/SOSM2026-09-21
05708296257997GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258000GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258017GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258024GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258031GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258048GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258321GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258338GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258345GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258352GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258369GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258376GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258383GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258390GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258406GN ReSoundGn Hearing A/SOSM2026-09-21
05708296434602GN HearingGn Hearing A/SOSM2026-09-21
05708296434770GN HearingGn Hearing A/SOSM2026-09-21
05708296434794GN HearingGn Hearing A/SOSM2026-09-21