23ga Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector

GUDID 10817489027728

KATALYST SURGICAL LLC

Ophthalmic laser system beam guide

• Primary Device ID: 10817489027728
• NIH Device Record Key: f937f681-6c7d-4c78-9121-5a9ccb83fda9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 23ga Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector
• Version Model Number: V6352-23AR
• Company DUNS: 007883297
• Company Name: KATALYST SURGICAL LLC
• Device Count: 10
• 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	00817489027721 [Unit of Use]
GS1	10817489027728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121187

FDA Product Code

• HQB: Photocoagulator And Accessories

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: 2019-04-11
• Device Publish Date: 2019-04-03

Devices Manufactured by KATALYST SURGICAL LLC

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• 00840096207613 - DEX TIPS™ Universal Slim Handle: 2026-01-12 DEX TIPS™ Universal Slim Handle
• 10817489025298 - Cyclophotocoagulation Probe, Quantel Connector: 2026-01-05
• 10817489025304 - Cyclophotocoagulation Probe, Iridex Connector: 2026-01-05
• 10817489024536 - Revolver Fiber: 2025-07-03
• 10817489024833 - Disposable Bipolar Focused Irrigating Forceps, 7", 0.5mm Straight Tips, Box of 5: 2025-07-03 Disposable Bipolar Focused Irrigating Forceps, 7", 0.5mm Straight Tips, Box of 5
• 10817489024840 - Disposable Bipolar Focused Irrigating Forceps, 7", 1.0mm Straight Tips, Box of 5: 2025-07-03 Disposable Bipolar Focused Irrigating Forceps, 7", 1.0mm Straight Tips, Box of 5
• 10817489024857 - Disposable Bipolar Focused Irrigating Forceps, 7", 1.5mm Straight Tips, Box of 5: 2025-07-03 Disposable Bipolar Focused Irrigating Forceps, 7", 1.5mm Straight Tips, Box of 5