FDA.reportPublic FDA data

Neuro Cochlear Implant System

Primary DI
03663227803068
Brand
Neuro Cochlear Implant System
Company
NEURELEC
Model
M80306
Device description
Insertion Fork
Published
2021-08-27
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
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

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
03663227803068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663227803068036632278030683663227803068

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant systemA battery-powered assembly of devices [cochlear implant (CI)] intended for the partial restoration of auditory sensation to a profoundly deaf person. It consists of an inner electrode array implanted in one cochlea and connected to a receiver-stimulator implanted near the ear; and an externally worn microphone-sound processor, battery pack, coil cable, and coil (transmitter). Sound waves are converted into electrical signals by the sound processor (transducer) and sent to the coil (transmitter) via the coil cable. The coil transmits the signals to the receiver-stimulator and ultimately to the cochlea via the electrode array. Dedicated implantation instruments may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-277-8119info@oticonmedicalusa.com

Regulatory Flags#

DUNS number
285420530
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
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
03663227001815Neuro Cochlear Implant System1815232021-11-12

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Primary DI, Brand, Company table
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