Slimline Endo SIS 550 Fiber

GUDID 17290109143061

LUMENIS LTD.

General/multiple surgical solid-state laser system
Primary Device ID17290109143061
NIH Device Record Key86f5c2b1-e7ae-4ba5-886b-5d8a6b8d8bfc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlimline Endo SIS 550 Fiber
Version Model NumberSlimline Endo SIS 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
GS107290109143064 [Primary]
GS117290109143061 [Package]
Contains: 07290109143064
Package: [3 Units]
In Commercial Distribution

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 Date2016-09-19

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