OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™

GUDID 07290109142968

Additional DM DIs: 07290109143910 07290109143927 07290109143934 07290109143941 07290109143958 07290109143965 07290109143972 07290109143989

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system
Primary Device ID07290109142968
NIH Device Record Keyfe80bd62-1368-4cb7-9542-f1db9067bf11
Commercial Distribution StatusIn Commercial Distribution
Brand NameOtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™
Version Model NumberKit for up to 007-xxxx, 110V
Company DUNS600166524
Company NameLUMENIS LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109142968 [Primary]
GS107290109143903 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


[07290109142968]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-29
Device Publish Date2016-09-19

On-Brand Devices [OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™ ]

07290109142968Additional DM DIs: 07290109143910 07290109143927 07290109143934 07290109143941 07290109143958 07
07290109142692Additional DM DIs: 07290109143910 07290109143927 07290109143934 07290109143941 07290109143958 07

Trademark Results [OtoScan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OTOSCAN
OTOSCAN
90624141 not registered Live/Pending
PhotoniCare, Inc.
2021-04-05
OTOSCAN
OTOSCAN
87356052 not registered Dead/Abandoned
NeuroLogica Corp.
2017-03-02
OTOSCAN
OTOSCAN
85752771 4479769 Live/Registered
GN Otometrics A/S
2012-10-12
OTOSCAN
OTOSCAN
85716306 not registered Dead/Abandoned
3DM Systems Acquisition, LLC
2012-08-29
OTOSCAN
OTOSCAN
74633921 1961203 Dead/Cancelled
STARKEY LABORATORIES, INC.
1995-01-24

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