FDA.reportPublic FDA data

Oticon

Primary DI
05707131336842
Brand
Oticon
Company
Oticon A/S
Model
188339
Device description
FM REC, AMIGO R12G2 216-218 MHZ C047
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
05707131336842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707131336842057071313368425707131336842

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
05708296394029BeltoneGn Hearing A/SOSM2026-10-05
05708296394036BeltoneGn Hearing A/SOSM2026-10-05
05708296394098BeltoneGn Hearing A/SOSM2026-10-05
05708296394104BeltoneGn Hearing A/SOSM2026-10-05
05708296394111BeltoneGn Hearing A/SOSM2026-10-05
05708296394128BeltoneGn Hearing A/SOSM2026-10-05
05708296394135BeltoneGn Hearing A/SOSM2026-10-05
05708296394197BeltoneGn Hearing A/SOSM2026-10-05
05708296394203BeltoneGn Hearing A/SOSM2026-10-05
05708296394210BeltoneGn Hearing A/SOSM2026-10-05
05708296394487BeltoneGn Hearing A/SOSM2026-10-05
05708296394494BeltoneGn Hearing A/SOSM2026-10-05
05708296394555BeltoneGn Hearing A/SOSM2026-10-05
05708296394562BeltoneGn Hearing A/SOSM2026-10-05
05708296394579BeltoneGn Hearing A/SOSM2026-10-05
05708296394586BeltoneGn Hearing A/SOSM2026-10-05
05708296394593BeltoneGn Hearing A/SOSM2026-10-05
05708296394654BeltoneGn Hearing A/SOSM2026-10-05
05708296394661BeltoneGn Hearing A/SOSM2026-10-05
05708296394678BeltoneGn Hearing A/SOSM2026-10-05
05708296397877BeltoneGn Hearing A/SOSM2026-10-05
05708296397884BeltoneGn Hearing A/SOSM2026-10-05
05708296397945BeltoneGn Hearing A/SOSM2026-10-05
05708296397952BeltoneGn Hearing A/SOSM2026-10-05
05708296397969BeltoneGn Hearing A/SOSM2026-10-05
05708296429455BeltoneGn Hearing A/SOSM2026-10-05
05708296429462BeltoneGn Hearing A/SOSM2026-10-05
05708296429523BeltoneGn Hearing A/SOSM2026-10-05
05708296429530BeltoneGn Hearing A/SOSM2026-10-05
05708296429547BeltoneGn Hearing A/SOSM2026-10-05