Digital AcuBlade™ Upgrade kit for UltraPulse® Sur

GUDID 07290109142166

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system
Primary Device ID07290109142166
NIH Device Record Key6305257a-37f4-445f-a2dd-3b7f5153f0b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDigital AcuBlade™ Upgrade kit for UltraPulse® Sur
Version Model NumberKit for 008-xxxx and above, 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 Numbertrue
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
GS107290109142166 [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 Date2016-08-30

On-Brand Devices [Digital AcuBlade™ Upgrade kit for UltraPulse® Sur]

07290109142708Digital AcuBlade™ Upgrade kit for UltraPulse® Sur
07290109142166Kit for 008-xxxx and above, 220V
07290109142159Kit for 008-xxxx and above, 110V
07290109142142Kit for up to 007-xxxx, 110V

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