STARKEY HEARING TECHNOLOGIES 43011-100

GUDID 00842318168481

STARKEY LABORATORIES, INC.

Hearing device remote control
Primary Device ID00842318168481
NIH Device Record Keyb9eb06ed-63b0-4f6f-96f7-82595cd439e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTARKEY HEARING TECHNOLOGIES
Version Model NumberSTARKEY HEARING TECHNOLOGIES REMOTE
Catalog Number43011-100
Company DUNS055461479
Company NameSTARKEY LABORATORIES, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100842318168481 [Primary]

FDA Product Code

OSMHearing aid, air conduction with wireless technology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-27
Device Publish Date2018-08-27

On-Brand Devices [STARKEY HEARING TECHNOLOGIES]

00842318168542STARKEY HEARING TECHNOLOGIES TV
00842318168535STARKEY HEARING TECHNOLOGIES TV
00842318168528STARKEY HEARING TECHNOLOGIES TV
00842318168511STARKEY HEARING TECHNOLOGIES TV
00842318168504STARKEY HEARING TECHNOLOGIES REMOTE MICROPHONE +
00842318168498STARKEY HEARING TECHNOLOGIES REMOTE MICROPHONE +
00842318168481STARKEY HEARING TECHNOLOGIES REMOTE
00842318168474STARKEY HEARING TECHNOLOGIES REMOTE
00842318168467STARKEY HEARING TECHNOLOGIES REMOTE
00842318168450STARKEY HEARING TECHNOLOGIES REMOTE
00842318174703STARKEY HEARING TECHNOLOGIES CHARGER
00842318174574STARKEY HEARING TECHNOLOGIES CHARGER
00842318174499STARKEY HEARING TECHNOLOGIES CHARGER
00842318174413STARKEY HEARING TECHNOLOGIES CHARGER
00842318174338STARKEY HEARING TECHNOLOGIES CHARGER
00842318173829STARKEY HEARING TECHNOLOGIES MINI REMOTE MICROPHON
00842318173607STARKEY HEARING TECHNOLOGIES MINI REMOTE MICROPHON
00842318173522STARKEY HEARING TECHNOLOGIES MINI REMOTE MICROPHON
00842318173447STARKEY HEARING TECHNOLOGIES MINI REMOTE MICROPHON
00842318176561STARKEY HEARING TECHNOLOGIES TABLE MICROPHONE
00842318176554STARKEY HEARING TECHNOLOGIES TABLE MICROPHONE
00842318176547STARKEY HEARING TECHNOLOGIES SURFLINK ADAPTER

Trademark Results [STARKEY HEARING TECHNOLOGIES]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STARKEY HEARING TECHNOLOGIES
STARKEY HEARING TECHNOLOGIES
87848030 not registered Live/Pending
Starkey Laboratories, Inc.
2018-03-23

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