Echo-Screen III 012625

GUDID 00382830044714

Echo-Screen III 4' OAE Cable

NATUS MEDICAL INCORPORATED

Evoked-potential audiometer Evoked-potential audiometer
Primary Device ID00382830044714
NIH Device Record Keyf058ff0c-7b84-4692-bad3-99c36246f154
Commercial Distribution Discontinuation2017-04-20
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEcho-Screen III
Version Model Number012625
Catalog Number012625
Company DUNS962519208
Company NameNATUS MEDICAL INCORPORATED
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 Numbertrue
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

Phone1-800-303-0306
EmailTechnical.Service@natus.com
Phone1-800-303-0306
EmailTechnical.Service@natus.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100382830044714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWJStimulator, Auditory, Evoked Response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-24

Devices Manufactured by NATUS MEDICAL INCORPORATED

00382830062190 - Natus2024-03-20 Intracranial Pressure and Temperature Monitor
10382830062289 - Natus2023-05-12 CRANIAL ACCESS KIT
10382830062296 - Natus2023-05-12 CRANIAL ACCESS KIT
10382830062302 - Natus2023-05-12 CRANIAL ACCESS KIT
10382830062319 - Natus2023-05-12 CRANIAL ACCESS KIT
10382830062326 - Natus2023-05-12 CRANIAL ACCESS KIT
10382830062333 - Natus2023-05-12 CRANIAL ACCESS KIT
10381780039310 - CAMINO®2020-05-06 Intracranial Pressure and Temperature Monitor

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.