FDA.reportPublic FDA data

Neuro Cochlear Implant System

Primary DI
03663227002362
Brand
Neuro Cochlear Implant System
Company
NEURELEC
Model
158004
Device description
SOUND PROCESSOR, NEURO2 ZTI C044
Published
2021-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCMImplant, Cochlear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCMImplant, CochlearUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200021000Neuro Cochlear Implant SystemOticon Medical2021-06-23MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663227002362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663227002362036632270023623663227002362

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant system sound processorThe non-sterile external portion of a cochlear implant system [cochlear implant (CI)] that typically consists of a battery-powered microphone/transmitter (transducer) designed to convert sound waves from the environment into electrical signals which are transmitted to the implantable portion of the device, via a coil, for the partial restoration of auditory sensation in a profoundly deaf person. Also known as a speech processor, it is typically worn like a behind-the-ear (BTE) hearing aid.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-277-8121info@oticonmedicalusa.com

Regulatory Flags#

DUNS number
285420530
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03663227801842Neuro Cochlear Implant SystemM801842021-10-06
03663227801859Neuro Cochlear Implant SystemM801852021-10-06
03663227002003Neuro Cochlear Implant System1799942021-08-30
03663227801781Neuro Cochlear Implant SystemM801782021-08-30
03663227801804Neuro Cochlear Implant SystemM801802021-08-30
03663227801811Neuro Cochlear Implant SystemM801812021-08-30
03663227801736Neuro Cochlear Implant SystemM801732021-08-27
03663227801743Neuro Cochlear Implant SystemM801742021-08-27
03663227801750Neuro Cochlear Implant SystemM801752021-08-27
03663227801774Neuro Cochlear Implant SystemM801772021-08-27
03663227801798Neuro Cochlear Implant SystemM801792021-08-27
03663227803068Neuro Cochlear Implant SystemM803062021-08-27
03663227803877Neuro Cochlear Implant SystemM803872021-08-27
03663227803884Neuro Cochlear Implant SystemM803882021-08-27
03663227001754Neuro Cochlear Implant System1815172021-11-12
03663227001761Neuro Cochlear Implant System1815182021-11-12
03663227001778Neuro Cochlear Implant System1815192021-11-12
03663227001785Neuro Cochlear Implant System1815202021-11-12
03663227001792Neuro Cochlear Implant System1815212021-11-12
03663227001808Neuro Cochlear Implant System1815222021-11-12

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