Dornier MedTech K2010291

GUDID 04049958001741

400 Micron Disposable Diode Laser Lightguide, 0.22 NA, 3.5 meter length, 0.76 mm outer diameter

Dornier MedTech Laser GmbH

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

• Primary Device ID: 04049958001741
• NIH Device Record Key: 07730009-6a36-4994-83b7-aad0d6f972ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dornier MedTech
• Version Model Number: 400 Micron Disposable NA 0.22
• Catalog Number: K2010291
• 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	04049958000119 [Package]; Package: box [10 Units]; In Commercial Distribution
GS1	04049958001741 [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: 2018-10-12
• Device Publish Date: 2018-09-11

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