FiberTech® M280202S

GUDID 04059497000433

LEONI Fiber Optics GmbH

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: 04059497000433
• NIH Device Record Key: e0a1b84f-452e-448e-a7fe-5309902574c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FiberTech®
• Version Model Number: FT IR600/720HCN-3/SL-SF-1750 003711C
• Catalog Number: M280202S
• Company DUNS: 342703174
• Company Name: LEONI Fiber Optics GmbH
• 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	04059497000198 [Primary]
GS1	04059497000433 [Package]; Contains: 04059497000198; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050738

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-29

On-Brand Devices [FiberTech®]

• 04260438610813: FT IR400/440PI-3/SM-F 500211L
• 04260438610806: FT IR600T-3/SGFM-F 000021L
• 04260438610417: FT IR400T-3/SGFM-F 000031L
• 04260438610400: FT IR600/720HCN-3/SL-SF-2000 012011L
• 04260438610776: FT IR600/660HCT-3/SL-F 130011L
• 04260438610387: FT IR400/420HCT-3/SL-F 130011L
• 04059497000679: FT IR600/720HCN-3/SL-SF-2050 0S2011F
• 04059497000471: FT IR400/440PI-3/SM-F 500211L
• 04059497000457: FT IR600/720HCN-3/SL-SF-2050 L12011F
• 04059497000440: FT IR600/720HCN-3/SL-SF-2050 L12011F
• 04059497000433: FT IR600/720HCN-3/SL-SF-1750 003711C
• 04059497000662: FT IR210/220A-2.5/SM-EC25 000311L
• 04059497000419: FT IR210/220A-2.5/SM-ES25 000311L
• 04059497000648: FT UV100/240AN-2.5/SM-EC23 300311L
• 04059497000631: FT IR200/220PI-2.5/SMI-EC23 5K0CK1F
• 04059497000624: FT IR210/220A-2.5/SM-EC23 000311L
• 04059497000617: FT IR200/220PI-2.5/SMI-ES23 5K0CK1F
• 04059497000365: FT IR210/220A-2.5/SM-ES23 000311L
• 04059497000334: FT IR550/605ST-3/SL-F 1500K3L
• 04059497000327: FT IR365/400ST-3/SL-F 1500K3L
• 04059497000310: FT IR272/300ST-3/SL-F 1500K3L
• 04059497000303: FT IR200/240ST-3/SL-F 1500K3L
• 04059497000532: FT IR550/605ST-3/SL-F 120011L
• 04059497000280: FT IR365/400ST-3/SL-F 120011L
• 04059497000501: FT IR273/300ST-3/SL-F 120011L
• 04059497000259: FT IR200/240ST-3/SL-F 120011L
• 04059497000242: FT IR600/720HCN-3/SF-2050 003001C