095896

GUDID 01816901021094

LEONI FIBER OPTICS, INC.

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 01816901021094
• NIH Device Record Key: cc75a572-e214-4754-92d0-2b7fd0deac1b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: LFS-272-RTSB
• Catalog Number: 095896
• 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	00816901021095 [Primary]
GS1	01816901021094 [Package]; Contains: 00816901021095; Package: [5 Units]; In Commercial Distribution
GS1	02816901021093 [Package]; 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-18

Devices Manufactured by LEONI FIBER OPTICS, INC.

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