Dornier Thulio K2016000

GUDID 04049958004551

Dornier Thulio

Dornier MedTech Laser GmbH

General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system

• Primary Device ID: 04049958004551
• NIH Device Record Key: fde54a17-79aa-4fa4-97bb-fb750f2966e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dornier Thulio
• Version Model Number: K2016000
• Catalog Number: K2016000
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049958004551 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-12-04
• Device Publish Date: 2023-01-27

Devices Manufactured by Dornier MedTech Laser GmbH

• 04049958004551 - Dornier Thulio: 2023-12-04Dornier Thulio
• 04049958004551 - Dornier Thulio: 2023-12-04 Dornier Thulio
• 04049958000171 - Dornier MedTech: 2018-10-15 Medilas Fibertome 8100 ND YAG Laser
• 04049958001383 - Dornier MedTech: 2018-10-15 Medilas D MultiBeam Diode Laser, Green Pilot Beam, D-Plug
• 04049958000096 - Dornier MedTech: 2018-10-15 600 Micron Disposable ND YAG Barefiber Laser Lightguide, 3.5 meter length, 1.0 mm outer diameter
• 04049958002090 - Dornier MedTech: 2018-10-15 Medilas D30 1064 Diode Laser, SMA
• 04049958002137 - Dornier MedTech: 2018-10-15 400 Micron Disposable Diode Laser Lightguide, 0.37 NA, 2.5 meter length, 0.76 mm outer diameter
• 04049958002229 - Dornier MedTech: 2018-10-15 Medilas D LiteBeam+ Diode Laser, 1470 nm, SMA
• 04049958002618 - Dornier MedTech: 2018-10-15 Medilas H30 Solvo Holmium Laser with wired footswitch