Bone Conductor B71W

GUDID 04260223140891

Bone conductor with patient response button for Sentiero

PATH medical GmbH

Evoked-potential audiometer
Primary Device ID04260223140891
NIH Device Record Keye7e3a1a9-75f3-40ce-9850-394496939ea3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Conductor B71W
Version Model Number100214
Company DUNS551540334
Company NamePATH medical GmbH
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 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
GS104260223140891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EWOAudiometer

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 Date2016-08-31

On-Brand Devices [Bone Conductor B71W ]

04260223142697Bone conductor for Sentiero
04260223140907Bone conductor for Sentiero Advanced / Sentiero Desktop
04260223140891Bone conductor with patient response button for Sentiero

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