SurgiTouch™ Upgrade kit for UltraPulse®

GUDID 07290109142661

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system
Primary Device ID07290109142661
NIH Device Record Keyc65f7776-8600-48e1-add0-ddb8f4b7473c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgiTouch™ Upgrade kit for UltraPulse®
Version Model NumberKit for up to 007-xxxx, 220V
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109142661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-14

On-Brand Devices [SurgiTouch™ Upgrade kit for UltraPulse® ]

07290109142661Kit for up to 007-xxxx, 220V
07290109142654Additional DM UDI: 07290109144252
07290109142647Kit for 008-xxxx and above, 110V
07290109142586Additional DM UDI: 07290109144252

Trademark Results [SurgiTouch]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURGITOUCH
SURGITOUCH
73792163 1628168 Dead/Cancelled
HO DENTAL COMPANY, INC.
1989-04-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.