Dornier MedTech K2011743

GUDID 04049958001307

Medilas D FlexiPulse Diode Laser, D-Plug

Dornier MedTech Laser GmbH

General/multiple surgical diode laser system

• Primary Device ID: 04049958001307
• NIH Device Record Key: f0ca83b4-55e2-4c01-8b44-e82316387249
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dornier MedTech
• Version Model Number: Medilas D FlexiPulse (D-Plug)
• Catalog Number: K2011743
• 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	04049958001307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070536

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: 2018-10-12
• Device Publish Date: 2018-09-11

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