SlimLine SIS™ EZ 550 LP

GUDID 07290109144597

LUMENIS LTD.

General/multiple surgical solid-state laser system
Primary Device ID07290109144597
NIH Device Record Key67d6e200-e3ec-4330-a472-b2f219d95b53
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlimLine SIS™ EZ 550 LP
Version Model NumberSlimLine SIS™ EZ 550 LP
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109144597 [Primary]
GS117290109144594 [Package]
Package: [3 Units]
In Commercial Distribution

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-17
Device Publish Date2022-03-09

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