addition ultra automix 2

GUDID EDET025231

DETAX GmbH

Earmould impression material
Primary Device IDEDET025231
NIH Device Record Keyda82caa7-d840-4922-9acf-0937a0539c3b
Commercial Distribution StatusIn Commercial Distribution
Brand Nameaddition ultra automix 2
Version Model Number02523
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
HIBCCEDET025231 [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 Date2024-09-05
Device Publish Date2024-08-28

Devices Manufactured by DETAX GmbH

EDET047181 - RS VIVO Denture Flex transparent 1000g2025-11-28
EDET047191 - RS VIVO Denture Flex pink transparent 1000g2025-11-28
EDET047201 - RS VIVO Denture Impact pink 1000g2025-11-28
EDET047211 - RS VIVO Denture Impact pink transparent 1000g2025-11-28
EDET047221 - RS VIVO IBT 1000g2025-11-28
EDET047231 - RS VIVO Splint Flex 1000g2025-11-28
EDET047241 - RS VIVO Splint Hard 1000g2025-11-28
EDET047011 - Freeprint denture flex pink-transparent 1.000g2025-11-26

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