OPTOS ADVANCE IMAGE SERVER

GUDID 05057056106397

OPTOS PUBLIC LIMITED COMPANY

Scanning-laser ophthalmic imaging system

• Primary Device ID: 05057056106397
• NIH Device Record Key: 33044476-776d-429f-bf1b-6b6c4bdaf88c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTOS ADVANCE IMAGE SERVER
• Version Model Number: A10639
• Company DUNS: 346013337
• Company Name: OPTOS PUBLIC LIMITED COMPANY
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05057056106397 [Primary]

FDA Product Code

• MYC: Ophthalmoscope,Laser,Scanning

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-05-27

On-Brand Devices [OPTOS ADVANCE IMAGE SERVER]

• 05057056106885: A10688
• 05057056106397: A10639