detax softwear 2.0 blue 40 shore 2x50ml

GUDID EDET042331

DETAX GmbH

Earmould, custom-made
Primary Device IDEDET042331
NIH Device Record Key9563867b-b0ef-46b0-8a43-3b3a0535f147
Commercial Distribution StatusIn Commercial Distribution
Brand Namedetax softwear 2.0 blue 40 shore 2x50ml
Version Model Number04233
Company DUNS343947949
Company NameDETAX GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDET042331 [Primary]

FDA Product Code

ESDHearing Aid, Air-Conduction, Prescription

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-13
Device Publish Date2023-02-03

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