098751

GUDID 02816901022274

LEONI FIBER OPTICS, INC.

Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 02816901022274
• NIH Device Record Key: 153a699a-3560-4e3a-aed5-a0ff57df15e7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: LFS-600-SF
• Catalog Number: 098751
• 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	00816901022276 [Primary]
GS1	01816901022275 [Package]; Contains: 00816901022276; Package: [5 Units]; In Commercial Distribution
GS1	02816901022274 [Package]; Contains: 01816901022275; Package: [25 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: 2021-04-09
• Device Publish Date: 2021-04-01

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