FiberTech® 095436

GUDID 01816901020653

LEONI FIBER OPTICS, INC.

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 01816901020653
• NIH Device Record Key: 5e050f20-c2df-422a-80cf-3a673924c988
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FiberTech®
• Version Model Number: LFS-940
• Catalog Number: 095436
• 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	00816901020654 [Primary]
GS1	01816901020653 [Package]; Contains: 00816901020654; Package: [5 Units]; In Commercial Distribution
GS1	02816901020652 [Package]; Package: [2 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: 2016-09-28

On-Brand Devices [FiberTech®]

• 02816901020898: LFR-200
• 01816901020882: LFS-800-RTSB
• 01816901020875: LFS-600-SF
• 01816901020820: LFS-200-RTSB
• 01816901020813: LFS-940-RTSB
• 01816901020806: LFS-550-RTSB
• 01816901020790: LFS-272-RTSB
• 02816901020782: LFS-365-RTSB
• 01816901020769: LFR-365-SB
• 01816901020752: LFR-272-SB
• 01816901020745: LFS-550-SB
• 01816901020738: LFS-365-SB
• 01816901020721: LFS-272-SB
• 01816901020714: LFS-272-RT
• 02816901020706: LFR-940
• 02816901020690: LFR-550
• 01816901020684: LFR-365
• 02816901020676: LFR-272
• 02816901020669: LFR-200
• 01816901020653: LFS-940
• 01816901020646: LFS-550
• 01816901020639: LFS-365
• 02816901020621: LFS-200
• 02816901020614: LFS-940-RT
• 02816901020607: LFS-550-RT
• 01816901020592: LFS-365-RT
• 02816901020584: LFS-200-RT
• 01816901020578: LFR-940-SB
• 01816901020561: LFR-550-SB
• 02816901020553: LFR-200-SB
• 02816901020546: LFS-940-SB
• 02816901020539: LFS-200-SB
• 01816901020189: LFS-600-GFL
• 01816901020172: LFR-600-SB