NeuLight® 095199

GUDID 01816901023753

LEONI FIBER OPTICS, INC.

Urogenital surgical laser system beam guide, reusable

• Primary Device ID: 01816901023753
• NIH Device Record Key: bdbebd7e-2b2d-47ca-ad96-5997e5c35930
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuLight®
• Version Model Number: WFR-550-SB
• Catalog Number: 095199
• 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: 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	00816901023754 [Primary]
GS1	01816901023753 [Package]; Contains: 00816901023754; Package: [5 Units]; In Commercial Distribution
GS1	02816901023752 [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: 2022-11-14
• Device Publish Date: 2022-11-04

On-Brand Devices [NeuLight®]

• 01816901023326: WFS-600
• 01816901023791: WFR-940-SB
• 01816901023784: WFS-600-SF
• 02816901023776: WFR-365-SB
• 02816901023769: WFR-940-SB
• 01816901023753: WFR-550-SB
• 01816901023746: WFR-200-SB
• 01816901023418: LFS-200-SB
• 01816901023425: LFS-365-SB
• 01816901023401: WFS-272-SB