Smart LIO

GUDID 07290109143835

LUMENIS INC.

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Primary Device ID07290109143835
NIH Device Record Key414d335c-6d86-47ed-9931-f3ff89fb4323
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmart LIO
Version Model NumberNA
Company DUNS043618763
Company NameLUMENIS INC.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109143835 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-22
Device Publish Date2023-06-14

On-Brand Devices [Smart LIO]

07290109143842NA
07290109143835NA
07290109140612NA

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