1077 AccuScreen

GUDID 05713315008856

1077 MADSEN AccuScreen, ABR/TE including standard accessories incl. probe

Gn Otometrics A/S

Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator Auditory stimulator
Primary Device ID05713315008856
NIH Device Record Key3dc4aad6-c85a-418c-a6c0-1e16974008c5
Commercial Distribution StatusIn Commercial Distribution
Brand Name1077 AccuScreen
Version Model Number8-04-13904
Company DUNS306633756
Company NameGn Otometrics A/S
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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105713315008856 [Primary]

FDA Product Code

GWJStimulator, Auditory, Evoked Response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

Devices Manufactured by Gn Otometrics A/S

05713315008856 - 1077 AccuScreen2021-05-041077 MADSEN AccuScreen, ABR/TE including standard accessories incl. probe
05713315008856 - 1077 AccuScreen2021-05-04 1077 MADSEN AccuScreen, ABR/TE including standard accessories incl. probe
05713315009037 - Natus2021-04-20 Aurical Freefit with charger (China only)
05713315009044 - Natus2021-04-20 Aurical Freefit without charger (China only)
05713315009051 - Natus2021-04-20 Aurical Freefit without charger (Japan only)
05713315008795 - Vemp Monitor2021-03-12 Vemp Monitor, Chartr EP
05713315008955 - AccuScreen2021-03-12 1077 AccuScreen ABR
05713315008962 - AccuScreen2021-03-12 1077 AccuScreen ABR/TE
05713315008979 - AccuScreen2021-03-12 1077 AccuScreen ABR/DP

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.