098322

GUDID 02816901021857

LEONI FIBER OPTICS, INC.

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 02816901021857
• NIH Device Record Key: 6870bc5a-24de-4f28-bd69-a58a8627ac7d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 0400-100-03
• Catalog Number: 098322
• 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: 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	00816901021859 [Primary]
GS1	01816901021858 [Package]; Contains: 00816901021859; Package: [5 Units]; In Commercial Distribution
GS1	02816901021857 [Package]; Contains: 01816901021858; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-20
• Device Publish Date: 2019-05-10

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