bioflex 40 transparent 4x50ml

GUDID EDET041691

DETAX GmbH

Earmould impression material
Primary Device IDEDET041691
NIH Device Record Keyff3493ab-ec2b-4689-92ee-058e17ddae8b
Commercial Distribution StatusIn Commercial Distribution
Brand Namebioflex 40 transparent 4x50ml
Version Model Number04169
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 Usefalse
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
HIBCCEDET041691 [Primary]

FDA Product Code

EWDProtector, Hearing (Insert)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-05
Device Publish Date2024-08-28

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EDET047241 - RS VIVO Splint Hard 1000g2025-11-28
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