pink putty 2 x 8 g

GUDID EDET035001

DETAX GmbH

Earmould impression material
Primary Device IDEDET035001
NIH Device Record Key5d93e8cb-bcc0-4ea5-af5e-26c2ea47e001
Commercial Distribution StatusIn Commercial Distribution
Brand Namepink putty 2 x 8 g
Version Model Number03500
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
HIBCCEDET035001 [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 Date2023-07-10
Device Publish Date2023-06-30

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.