Dornier MedTech K1001291

GUDID 04049958000058

600 Micron Disposable ND YAG Nozzle Tip Laser Lightguide, 3.5 meter length, 2.1 mm outer diameter

Dornier MedTech Laser GmbH

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

• Primary Device ID: 04049958000058
• NIH Device Record Key: b4b3892c-3b1f-4f99-a127-9f61616abc1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dornier MedTech
• Version Model Number: 600 Micron Disposable Nozzle Tip
• Catalog Number: K1001291
• 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	04049958000058 [Package]; Contains: 04049958001529; Package: box [10 Units]; In Commercial Distribution
GS1	04049958001529 [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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