Ciliprobe Transsceral Cyclophotocoagulation Probe

GUDID 10817489025151

KATALYST SURGICAL LLC

Ophthalmic fibreoptic light instrument, single-use

• Primary Device ID: 10817489025151
• NIH Device Record Key: c16b6979-318e-4ba5-b8ec-66bc75820e53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ciliprobe Transsceral Cyclophotocoagulation Probe
• Version Model Number: D4700A
• Company DUNS: 007883297
• Company Name: KATALYST SURGICAL LLC
• Device Count: 5
• DM Exempt: true
• 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	00817489025154 [Unit of Use]
GS1	10817489025151 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-07-21

On-Brand Devices [Ciliprobe Transsceral Cyclophotocoagulation Probe]

• 10817489025168: Quantel connector
• 10817489025151: D4700A