Otoform® A softX 8801

GUDID E23988011

No.

Dreve Otoplastik GmbH

Earmould impression kit
Primary Device IDE23988011
NIH Device Record Keyd2330525-72f9-4d2a-bc58-8fa707b94ec1
Commercial Distribution StatusIn Commercial Distribution
Brand NameOtoform® A softX
Version Model Number8801
Catalog Number8801
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
HIBCCE23988011 [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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