IRIDEX 1002072A30.E V1

GUDID 08056098470876

COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL

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• Primary Device ID: 08056098470876
• NIH Device Record Key: c68dee12-6cc9-4610-8ef3-42ef08b6302a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRIDEX
• Version Model Number: SL 9800 3X
• Catalog Number: 1002072A30.E V1
• Company DUNS: 432448470
• Company Name: COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	08056098470876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992836

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-18
• Device Publish Date: 2020-12-10

On-Brand Devices [IRIDEX]

• 08056098470883: SL 9900 3X
• 08056098470876: SL 9800 3X
• 08056098470654: SL 980 5X
• 08056098470272: SL 9800 5X
• 08056098470265: SL 9900 5X