Genie Medical 275209

GUDID 05712149027637

ISO FILE, GENIE MEDICAL BAHS 2024.2 US VA

Oticon Medical AB

Audiometric/hearing device software
Primary Device ID05712149027637
NIH Device Record Keyfaebc001-d74c-4a8b-a17d-26aac65a867e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenie Medical
Version Model Number275209
Catalog Number275209
Company DUNS554563994
Company NameOticon Medical AB
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105712149027637 [Primary]

FDA Product Code

LXBHearing Aid, Bone Conduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-16
Device Publish Date2024-08-08

On-Brand Devices [Genie Medical]

05712149027644FLEX LINK GENIE MEDICAL BAHS 24.2
05712149027637ISO FILE, GENIE MEDICAL BAHS 2024.2 US VA
05712149027590SALES PACK, GENIE MEDICAL BAHS 2024.2 USB

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