Dornier Thulio K2016000

GUDID 04049958004551

Dornier Thulio

Dornier MedTech Laser GmbH

General/multiple surgical solid-state laser system
Primary Device ID04049958004551
NIH Device Record Keyfde54a17-79aa-4fa4-97bb-fb750f2966e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDornier Thulio
Version Model NumberK2016000
Catalog NumberK2016000
Company DUNS389567538
Company NameDornier MedTech Laser GmbH
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
GS104049958004551 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-12-04
Device Publish Date2023-01-27

Devices Manufactured by Dornier MedTech Laser GmbH

04049958004551 - Dornier Thulio2023-12-04Dornier Thulio
04049958004551 - Dornier Thulio2023-12-04 Dornier Thulio
04049958000171 - Dornier MedTech2018-10-15 Medilas Fibertome 8100 ND YAG Laser
04049958001383 - Dornier MedTech2018-10-15 Medilas D MultiBeam Diode Laser, Green Pilot Beam, D-Plug
04049958000096 - Dornier MedTech2018-10-15 600 Micron Disposable ND YAG Barefiber Laser Lightguide, 3.5 meter length, 1.0 mm outer diameter
04049958002090 - Dornier MedTech2018-10-15 Medilas D30 1064 Diode Laser, SMA
04049958002137 - Dornier MedTech2018-10-15 400 Micron Disposable Diode Laser Lightguide, 0.37 NA, 2.5 meter length, 0.76 mm outer diameter
04049958002229 - Dornier MedTech2018-10-15 Medilas D LiteBeam+ Diode Laser, 1470 nm, SMA
04049958002618 - Dornier MedTech2018-10-15 Medilas H30 Solvo Holmium Laser with wired footswitch

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