addition Junior/DIC 4 x 50 ml

GUDID EDET041601

DETAX GmbH

Earmould impression material
Primary Device IDEDET041601
NIH Device Record Keye901c3ca-2904-42b9-8651-dc50ca3c81d5
Commercial Distribution StatusIn Commercial Distribution
Brand Nameaddition Junior/DIC 4 x 50 ml
Version Model Number04160
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
HIBCCEDET041601 [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

EDET045581 - medicalprint nobreak blue-transparent 1000g2025-12-30
EDET045631 - medicalprint nobreak dark grey1000g2025-12-30
EDET045641 - medicalprint nobreak green opaque 1000g2025-12-30
EDET045681 - medicalprint nobreak dark neon yellow 1000g2025-12-30
EDET045691 - medicalprint nobreak purple 1000g2025-12-30
EDET045701 - medicalprint nobreak red-transparent 1000g2025-12-30
EDET045741 - medicalprint nobreak white 1000g2025-12-30
EDET046311 - medicalprint nobreak orange-transparent 1000g2025-12-30

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.