FDA.report

Oticon

Primary DI
05707131249593
Brand
Oticon
Company
Oticon A/S
Model
126158
Device description
ALTA PRO, KIT 312 WL DIR 85 R V
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
05707131249593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707131249593057071312495935707131249593

GMDN Terms

TermDefinition
In-the-ear air-conduction hearing aidA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

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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