096644

GUDID 02816901021475

LEONI FIBER OPTICS, INC.

Urogenital surgical laser system beam guide, reusable

• Primary Device ID: 02816901021475
• NIH Device Record Key: e0185be0-0f5e-46ee-9d2d-f65d068315ad
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DFR-550-SB
• Catalog Number: 096644
• Company DUNS: 039281260
• Company Name: LEONI FIBER OPTICS, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00816901021477 [Primary]
GS1	01816901021476 [Package]; Contains: 00816901021477; Package: [5 Units]; In Commercial Distribution
GS1	02816901021475 [Package]; Contains: 01816901021476; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050738

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-15
• Device Publish Date: 2016-12-12

Devices Manufactured by LEONI FIBER OPTICS, INC.

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• 01816901023425 - NeuLight®: 2023-03-27
• 01816901023418 - NeuLight®: 2023-02-20
• 01816901023470 - Typenex Medical: 2023-02-13
• 01816901023708 - Typenex Medical: 2023-02-13
• 01816901023746 - NeuLight®: 2022-11-14
• 01816901023753 - NeuLight®: 2022-11-14
• 02816901023769 - NeuLight®: 2022-11-14