23ga Flex Tapered Illum Laser Probe, Iridex Connector/Short 19ga; Box of 10

GUDID 10817489024710

23ga Tapered Flexible Curved Illuminated Laser Probe, Iridex Connector/ Short 19ga Needle, Flush Tip, Widefield

KATALYST SURGICAL LLC

Ophthalmic fibreoptic light instrument, single-use

• Primary Device ID: 10817489024710
• NIH Device Record Key: 8447142a-4fe5-4666-9dc5-1ba1f03fa8a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 23ga Flex Tapered Illum Laser Probe, Iridex Connector/Short 19ga; Box of 10
• Version Model Number: V6315-23AV
• Company DUNS: 007883297
• Company Name: KATALYST SURGICAL LLC
• Device Count: 10
• 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	00817489024713 [Unit of Use]
GS1	10817489024710 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-03-24

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