audioprint L-2 FLX I MSI A4020230

GUDID EPRCA4020230

audioprint L-2 FLX I MSI 100 g; clear transparent

pro3dure medical GmbH

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Primary Device IDEPRCA4020230
NIH Device Record Key45ee2aba-765a-4345-abeb-1c0a08eec9f2
Commercial Distribution StatusIn Commercial Distribution
Brand Nameaudioprint L-2 FLX I MSI
Version Model Number100 g - Clear Transparent
Catalog NumberA4020230
Company DUNS312947842
Company Namepro3dure medical 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com
Phone+4923749200500
Emailinfo@pro3dure.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEPRCA4020230 [Primary]

FDA Product Code

ESDHearing Aid, Air Conduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-26
Device Publish Date2023-10-18

Devices Manufactured by pro3dure medical GmbH

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EPRCA0034150 - otosil SL-12023-10-26 otosil SL-1 250 g; clear transparent
EPRCA0034151 - otosil SL-12023-10-26 otosil SL-1 100 g; clear transparent
EPRCA0034160 - otosil SL-1 I MSI2023-10-26 otosil SL-1 I MSI 250 g; clear transparent
EPRCA0034300 - otosil protect 50 I MSI 2023-10-26 otosil protect 50 I MSI 8 double-cartridges with 2x24 ml each
EPRCA0034301 - otosil protect 50 I MSI 2023-10-26 otosil protect 50 I MSI 8 double-cartridges with 2x24 ml each
EPRCA0034302 - otosil protect 50 I MSI 2023-10-26 otosil protect 50 I MSI 8 double-cartridges with 2x24 ml each

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