Neuro Cochlear Implant System

GUDID 03663227003956

TAMPER, NEURO2 TOOL

NEURELEC

Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor Cochlear implant system sound processor
Primary Device ID03663227003956
NIH Device Record Keyadff6c57-4c64-4052-9646-c1a8d5837c94
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro Cochlear Implant System
Version Model Number185326
Company DUNS285420530
Company NameNEURELEC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com
Phone1-888-277-8060
Emailinfo@oticonmedicalusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103663227003956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, Cochlear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-06
Device Publish Date2021-08-27

On-Brand Devices [Neuro Cochlear Implant System]

03663227803884Neuro Zti screwdriver blade
03663227803877Neuro Zti screwdriver handle
03663227803068Insertion Fork
03663227801798Neuro Zti Dummy Magnet
03663227801774Neuro Zti Magnet Extractor
03663227801750Insertion forceps
03663227801743Neuro Zti Fixation Screws
03663227801736Neuro Zti screwdriver
03663227004014Programming Device, Left Wired
03663227004007Programming Device, Right Wired
03663227003956TAMPER, NEURO2 TOOL
03663227003864PACKING SET, CHARGEUR
03663227002355PACKING SET, THIN SAFETY LINE
03663227002140CLIP, NEURO2
03663227002126EAR PLUG, RETENTION KIT NEURO2
03663227801811Probe Array
03663227801804Neuro Zti implant indicator
03663227801781Neuro Zti Magnet
03663227003949SAFETY LINE, CI
03663227003840CARE KIT, NEURO2
03663227002003Neuro processor indicator
03663227801859Neuro Zti EVO
03663227801842Neuro ZtiCLA
03663227002430SOUND PROCESSOR, NEURO2 ZTI C098
03663227002423SOUND PROCESSOR, NEURO2 ZTI C094
03663227002416SOUND PROCESSOR, NEURO2 ZTI C093
03663227002409SOUND PROCESSOR, NEURO2 ZTI C092
03663227002393SOUND PROCESSOR, NEURO2 ZTI C091
03663227002379SOUND PROCESSOR, NEURO2 ZTI C057
03663227002362SOUND PROCESSOR, NEURO2 ZTI C044
03663227001976CI-LINK OPERATING ROOM KIT (ZTI)
03663227001969CI-LINK FITTING ROOM KIT
03663227001631SET, SOUND PROCESSOR NEURO2 ZTI C098
03663227001624SET, SOUND PROCESSOR NEURO2 ZTI C094
03663227001617SET, SOUND PROCESSOR NEURO2 ZTI C093
03663227001600SET, SOUND PROCESSOR NEURO2 ZTI C092
03663227001594SET, SOUND PROCESSOR NEURO2 ZTI C091
03663227001587SET, SOUND PROCESSOR NEURO2 ZTI C090
03663227001570SET, SOUND PROCESSOR NEURO2 ZTI C063
03663227001563SET, SOUND PROCESSOR NEURO2 ZTI C058
03663227001556SET, SOUND PROCESSOR NEURO2 ZTI C057
03663227001549SET, SOUND PROCESSOR NEURO2 ZTI C044
03663227001532Genie Medical CI Fitting Software
03663227001471SOUND PROCESSOR, NEURO2 ZTI C063
03663227001464SOUND PROCESSOR, NEURO2 ZTI C090
03663227000894CI-Link Unit Programming System
03663227002386SOUND PROCESSOR, NEURO2 ZTI C058

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