Otoform® A softX 2956

GUDID E23929561

No.

Dreve Otoplastik GmbH

Earmould impression kit
Primary Device IDE23929561
NIH Device Record Key935cc3a1-54fb-48e5-a465-7c25e0ef73f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameOtoform® A softX
Version Model Number2956
Catalog Number2956
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
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23929561 [Primary]

FDA Product Code

LDGKit, earmold, impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-22
Device Publish Date2022-08-12

On-Brand Devices [Otoform® A softX ]

E2398801M1No.
E23988011No.
E23929561No.
E23988021No.
E2398802M1No.
E2398802ST1No.
E2398802AU1No.

Trademark Results [Otoform]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OTOFORM
OTOFORM
79212229 5383052 Live/Registered
Dreve Otoplastik GmbH
2017-05-18

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