OtoLase™ Curved Tip SA-20055400

GUDID 17290109146802

SA-20055400 Box: AC-20055390

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system
Primary Device ID17290109146802
NIH Device Record Keyff32242b-7f93-4a3a-90ab-6b4b76e4dd41
Commercial Distribution StatusIn Commercial Distribution
Brand NameOtoLase™ Curved Tip
Version Model NumberOtoLase™ Curved Tip
Catalog NumberSA-20055400
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
GS107290109146805 [Primary]
GS117290109146802 [Package]
Contains: 07290109146805
Package: [12 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 Date2022-09-12
Device Publish Date2022-09-04

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