SlimLine EZ 550 Fiber

GUDID 07290109142050

LUMENIS LTD.

General/multiple surgical solid-state laser system
Primary Device ID07290109142050
NIH Device Record Keyba727f0e-aa2a-4c78-838c-92b828627bba
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlimLine EZ 550 Fiber
Version Model NumberSlimLine EZ 550 Fiber
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109142050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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 [SlimLine EZ 550 Fiber]

07290109142050SlimLine EZ 550 Fiber
17290109140183Slimline EZ 550 Fiber

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