Dornier MedTech K2014600

GUDID 04049958004025

Medilas H35 Holmium Laser with wired footswitch

Dornier MedTech Laser GmbH

Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system

• Primary Device ID: 04049958004025
• NIH Device Record Key: f0b68115-b5cf-467d-9e99-957fa4c418cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dornier MedTech
• Version Model Number: Medilas H35 Laser
• Catalog Number: K2014600
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049958004025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180350

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-15
• Device Publish Date: 2018-09-13

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,