Cili Probes (Cyclophotocoagulation)

GUDID 00840096211368

KATALYST SURGICAL LLC

Ophthalmic laser system beam guide

• Primary Device ID: 00840096211368
• NIH Device Record Key: 0b1e06a3-7e78-4331-9ed6-b561ba96e0de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cili Probes (Cyclophotocoagulation)
• Version Model Number: 620231
• Company DUNS: 007883297
• Company Name: KATALYST SURGICAL LLC
• Device Count: 5
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840096211368 [Unit of Use]
GS1	10840096211365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163632

FDA Product Code

• LQJ: Lens, Surgical, Laser, Accesssory, Ophthalmic Laser

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: 2020-03-12
• Device Publish Date: 2020-03-04

Devices Manufactured by KATALYST SURGICAL LLC

• 00840096206128 - 23ga ISOCLEAN™ Capsulorhexis Forceps, Blunt Tips, Gold: 2025-04-04 23ga ISOCLEAN™ Capsulorhexis Forceps, Blunt Tips, Gold
• 00840096206340 - 23ga ISOCLEAN™ Serrated Forceps, Curved Shaft, Gold: 2025-04-04 23ga ISOCLEAN™ Serrated Forceps, Curved Shaft, Gold
• 00840096206357 - 23ga ISOCLEAN™ Serrated Forceps, Straight Shaft, Gold: 2025-04-04 23ga ISOCLEAN™ Serrated Forceps, Straight Shaft, Gold
• 00840096208344 - ISOCLEAN™ Johnston Extractor Forceps: 2025-04-04 ISOCLEAN™ Johnston Extractor Forceps
• 00840096208443 - 23ga iQ™ Capsulorhexis Forceps, Blunt, Gold: 2025-04-04 23ga iQ™ Capsulorhexis Forceps, Blunt, Gold
• 00840096208450 - 23ga iQ™ MICS Capsulorhexis Forceps, Gold: 2025-04-04 23ga iQ™ MICS Capsulorhexis Forceps, Gold
• 00840096209525 - 23ga iQ™ Pyramid Tip Forceps: 2025-04-04 23ga iQ™ Pyramid Tip Forceps
• 00840096209532 - 25ga iQ™ Pyramid Tip Forceps, Gold: 2025-04-04 25ga iQ™ Pyramid Tip Forceps, Gold