FDA.report

Oticon

Primary DI
05707131336767
Brand
Oticon
Company
Oticon A/S
Model
188324
Device description
FM REC, AMIGO R12G2 169-187 MHZ C046
Published
2018-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications

CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707131336767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707131336767057071313367675707131336767

GMDN Terms

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

Contacts

PhoneEmail
+4539177100hama@oticon.com

Regulatory Flags

DUNS number
305839946
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
05707131379399Oticon2148162020-05-20
05707131357588Oticon2044522019-08-22
05707131357595Oticon2044532019-08-22
05707131357601Oticon2044542019-08-22
05707131357618Oticon2044552019-08-22
05707131357793Oticon2046702019-08-22
05707131357809Oticon2046712019-08-22
05707131357847Oticon2046752019-08-22
05707131399724Oticon2251192020-12-17
05707131399731Oticon2251202020-12-17
05707131399748Oticon2251212020-12-17
05707131399755Oticon2251222020-12-17
05714464006847Oticon2218752020-12-17
05714464006854Oticon2218842020-12-17
05714464006861Oticon2218932020-12-17
05714464007189Oticon2218672020-12-17
05714464007196Oticon2218682020-12-17
05714464007202Oticon2218692020-12-17
05714464007219Oticon2218702020-12-17
05714464007226Oticon2218712020-12-17

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05714880292237WidexWidex A/SOSM2026-05-22
05714880292244WidexWidex A/SOSM2026-05-22
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05714880292312WidexWidex A/SOSM2026-05-22
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05714880292343WidexWidex A/SOSM2026-05-22
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