Fotoplast® Gel 44841

GUDID E239448411

No.

Dreve Otoplastik GmbH

Earmould, custom-made
Primary Device IDE239448411
NIH Device Record Key50921def-1888-4028-85d6-287080f95166
Commercial Distribution StatusIn Commercial Distribution
Brand NameFotoplast® Gel
Version Model Number44841
Catalog Number44841
Company DUNS315808340
Company NameDreve Otoplastik 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

Customer Support Contacts

Phone+49230388070
Emailotoplastik@dreve.de

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE239448411 [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 Date2023-01-12
Device Publish Date2023-01-04

On-Brand Devices [Fotoplast® Gel]

E239448211No.
E239448111No.
E239447911No.
E239446911No.
E239446511No.
E239446221No.
E239446121No.
E239448411No.
E239448311No.

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