PSS Urology, Inc. 097231

GUDID 02816901022861

LEONI FIBER OPTICS, INC.

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 02816901022861
• NIH Device Record Key: c95f50f8-dfbd-4127-99d4-41af9771081e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PSS Urology, Inc.
• Version Model Number: LFS-550-RTSB
• Catalog Number: 097231
• 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: true
• 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	00816901022863 [Primary]
GS1	01816901022862 [Package]; Contains: 00816901022863; Package: [5 Units]; In Commercial Distribution
GS1	02816901022861 [Package]; Contains: 01816901022862; 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: 2021-06-14
• Device Publish Date: 2021-06-05

On-Brand Devices [PSS Urology, Inc.]

• 01816901022879: LFS-940-RTSB
• 02816901022861: LFS-550-RTSB
• 01816901023029: LFS-365-RTSB