096644

GUDID 02816901021475

LEONI FIBER OPTICS, INC.

Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable 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

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