IRIDEX 100213A50.E V1

GUDID 08056098470654

COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL

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• Primary Device ID: 08056098470654
• NIH Device Record Key: b5d9053f-e050-4a88-888d-92b313d32662
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRIDEX
• Version Model Number: SL 980 5X
• Catalog Number: 100213A50.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	08056098470654 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-08
• Device Publish Date: 2016-09-30

On-Brand Devices [IRIDEX]

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