Diode laser FOX 1064 nm. LS03200

GUDID 04260155593017

FOX 1064 nm Diode laser, aiming beam 532 nm, coupling 300 um

A.R.C. Laser GmbH

General/multiple surgical diode laser system

• Primary Device ID: 04260155593017
• NIH Device Record Key: c7ad3669-e529-47b8-bc10-1af2a57f17a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diode laser FOX 1064 nm.
• Version Model Number: LS03200
• Catalog Number: LS03200
• Company DUNS: 314885641
• Company Name: A.R.C. 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	04260155593017 [Primary]
GS1	04260155593024 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073322

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: 2019-11-27
• Device Publish Date: 2019-11-19

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• 04260155593017 - Diode laser FOX 1064 nm.: 2019-11-27FOX 1064 nm Diode laser, aiming beam 532 nm, coupling 300 um
• 04260155593017 - Diode laser FOX 1064 nm.: 2019-11-27 FOX 1064 nm Diode laser, aiming beam 532 nm, coupling 300 um
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