OtoLase™ Straight Tip Package

GUDID 17290109142606

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system
Primary Device ID17290109142606
NIH Device Record Keyf4abd7d3-25c2-41da-9989-4d78cffbdd5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOtoLase™ Straight Tip Package
Version Model NumberOtoLase™ Straight Tip Package
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
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx

Device Dimensions

Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter
Lumen/Inner Diameter250 Micrometer
Outer Diameter700 Micrometer
Length65 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109142609 [Primary]
GS117290109142606 [Package]
Contains: 07290109142609
Package: [12 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 Date2016-10-05

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