Dornier MedTech K1010500

GUDID 04049958000096

600 Micron Disposable ND YAG Barefiber Laser Lightguide, 3.5 meter length, 1.0 mm outer diameter

Dornier MedTech Laser GmbH

General/multiple surgical laser system beam guide, single-use, sterile

• Primary Device ID: 04049958000096
• NIH Device Record Key: df03dded-fc41-400a-9fa5-45794c0a39bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dornier MedTech
• Version Model Number: 600 Micron Disposable Barefiber
• Catalog Number: K1010500
• Company DUNS: 389567538
• Company Name: Dornier MedTech Laser GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049958000096 [Package]; Contains: 04049958001673; Package: box [10 Units]; In Commercial Distribution
GS1	04049958001673 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991183

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-15
• Device Publish Date: 2018-09-12

On-Brand Devices [Dornier MedTech]

• 04049958004032: Medilas H35 Holmium Laser with wireless footswitch
• 04049958004025: Medilas H35 Holmium Laser with wired footswitch
• 04049958003981: 600 Micron D Luer/SMA Ident Calibration Lightguide, Urobeam Laser
• 04049958003967: 600 Micron ND Laser Calibration Lightguide, Luer Lock
• 04049958003707: Medilas H30 Solvo Holmium Laser with wireless footswitch 3
• 04049958002861: Medilas HRM UroPulse Holmium Laser with wireless footswitch
• 04049958002854: Medilas H30 Solvo Holmium Laser with wireless footswitch
• 04049958002625: Medilas HRM UroPulse Holmium Laser with wired footswitch
• 04049958002618: Medilas H30 Solvo Holmium Laser with wired footswitch
• 04049958002441: Medilas D LiteBeam+ Diode Laser, 1470 nm, D-Plug
• 04049958002229: Medilas D LiteBeam+ Diode Laser, 1470 nm, SMA
• 04049958002151: 600 Micron Disposable Diode Laser Lightguide, 2.5 meter length, 1.07 mm outer diameter
• 04049958002137: 400 Micron Disposable Diode Laser Lightguide, 0.37 NA, 2.5 meter length, 0.76 mm outer diameter
• 04049958002113: 550 Micron 5X Reusable Lightguide, 150 watt, bare fiber tip, 3.5 meter length, 0.78 mm outer dia
• 04049958002090: Medilas D30 1064 Diode Laser, SMA
• 04049958001444: 600 Micron Disposable Diode Laser Lightguide, 60 watt, 3.5 meter length, 1.07 mm outer diameter
• 04049958001130: 400 Micron Disposable Laser Lightguide, 0.37NA, 3.5 meter length, 0.76 mm outer diameter
• 04049958001741: 400 Micron Disposable Diode Laser Lightguide, 0.22 NA, 3.5 meter length, 0.76 mm outer diameter
• 04049958000096: 600 Micron Disposable ND YAG Barefiber Laser Lightguide, 3.5 meter length, 1.0 mm outer diameter
• 04049958000621: 600 Micron Disposable ND YAG Threaded Nozzle Tip Laser Lightguide, 3.5 meter length, 2.2 mm oute
• 04049958000614: 600 Micron Disposable ND YAG Nozzle Tip Laser Lightguide, 3.5 meter length, 1.8 mm outer diamete
• 04049958000058: 600 Micron Disposable ND YAG Nozzle Tip Laser Lightguide, 3.5 meter length, 2.1 mm outer diamete
• 04049958000072: 600 Micron Disposable Diode Laser Lightguide, 3.5 meter length, 1.07 mm outer diameter
• 04049958001383: Medilas D MultiBeam Diode Laser, Green Pilot Beam, D-Plug
• 04049958001307: Medilas D FlexiPulse Diode Laser, D-Plug
• 04049958000225: Medilas D MultiBeam Diode Laser, D-Plug
• 04049958000218: Medilas D LiteBeam+ Diode Laser, D-Plug
• 04049958000171: Medilas Fibertome 8100 ND YAG Laser
• 04049958000065: 10 Units of 600 Micron Disposable ND YAG Laser Lightguide with Rinsing Tube, 3.5 meter length,