LEONI™ 099069

GUDID 01816901023111

LEONI FIBER OPTICS, INC.

Urogenital surgical laser system beam guide, reusable

• Primary Device ID: 01816901023111
• NIH Device Record Key: edc7959b-84f7-4527-b0ee-cc6f18f7888a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEONI™
• Version Model Number: LFR-940-SB
• Catalog Number: 099069
• Company DUNS: 039281260
• Company Name: LEONI FIBER OPTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	00816901023112 [Primary]
GS1	01816901023111 [Package]; Contains: 00816901023112; Package: [5 Units]; In Commercial Distribution
GS1	02816901023110 [Package]; Package: [2 Units]; In Commercial Distribution

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: 2022-03-01
• Device Publish Date: 2022-02-21

On-Brand Devices [LEONI™]

• 01816901022343: LFS-600-SF
• 02816901022311: LFR-365-SB
• 01816901022305: LFS-365-SB
• 02816901022298: LFR-272-SB
• 01816901022282: LFS-272-SB
• 01816901022800: LFS-400-SB
• 01816901022794: LFR-365-SB
• 02816901022779: LFR-272-SB
• 02816901022762: LFR-200-SB
• 01816901022756: LFS-550-SB
• 02816901022748: LFS-940-RTSB
• 01816901022732: LFS-550-RTSB
• 01816901022725: LFS-940-SB
• 02816901022717: LFS-365-5MSB
• 02816901022700: LFS-365-RTSB
• 02816901022694: LFS-365-SB
• 01816901022688: LFS-365-RT
• 01816901022657: LFS-272-RTSB
• 02816901022649: LFS-272-RTSB
• 01816901022633: LFS-272-SB
• 01816901022626: LFS-200-RTSB
• 02816901022618: LFS-200-RTSB
• 01816901022602: LFS-200-RTSB
• 01816901022596: LFS-200-SB
• 01816901022015: LFS-272-RT
• 01816901022008: LFS-200-RT
• 02816901022922: LFR-800-SB
• 02816901022915: LFS-800-SB
• 01816901022909: LFR-940-SB
• 01816901022893: LFR-550-SB
• 02816901022786: LFR-365-SB
• 01816901022930: LFR-600-SB
• 01816901022039: LFS-600-GFL
• 01816901023104: LFR-550-SB
• 02816901023127: LFS-940-SB
• 01816901023111: LFR-940-SB
• 01816901022978: LFR-200-SB
• 01816901022329: LFS-200-SB