LEONI™ 098900

GUDID 01816901022350

Weinert Fiber Optics, Inc.

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 01816901022350
• NIH Device Record Key: 12de4970-835d-4962-a2df-62961e60a8a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEONI™
• Version Model Number: LFS-600-SF
• Catalog Number: 098900
• Company DUNS: 039281260
• Company Name: Weinert 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	00816901022351 [Primary]
GS1	01816901022350 [Package]; Contains: 00816901022351; Package: [5 Units]; In Commercial Distribution
GS1	02816901022359 [Package]; Package: [5 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-02
• Device Publish Date: 2021-05-28

On-Brand Devices [LEONI™]

• 02816901022489: LFR-400-SB
• 01816901022473: LFR-550-SB
• 01816901022466: LFR-550-SB
• 01816901022459: LFS-600-SB
• 02816901022441: LFS-600-SB
• 02816901022434: LFS-800-SB
• 01816901022428: LFR-200-SB
• 01816901022411: LFR-200-SB
• 01816901022404: LFR-940-SB
• 02816901022366: 098741
• 01816901022350: LFS-600-SF