OPTOS ADVANCE

GUDID 05057056905709

OPTOS PUBLIC LIMITED COMPANY

Radiology picture archiving and communication system application software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software Ophthalmology PACS software

• Primary Device ID: 05057056905709
• NIH Device Record Key: 07a76e72-532e-4882-87b5-a0f9031f92c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTOS ADVANCE
• Version Model Number: S90570
• 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: false
• Manufacturing Date: false
• 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	05057056905709 [Primary]

FDA Product Code

• NFJ: System, Image Management, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-05-27

Devices Manufactured by OPTOS PUBLIC LIMITED COMPANY

• 05057056107509 - OCT Ophthalmoscope: 2019-11-06 A desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and targeted navigated optical c
• 05057056905709 - OPTOS ADVANCE: 2018-09-24
• 05057056905709 - OPTOS ADVANCE: 2018-09-24
• 05057056003856 - Optos OCT/SLO: 2018-07-06
• 05057056100920 - Panoramic Opthalmoscope: 2018-07-06
• 05057056107004 - OCT Ophthalmoscope: 2018-05-03 The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and dig
• 05057056010212 - Panoramic Ophthalmoscope: 2018-03-29
• 05057056100210 - Panoramic Ophthalmoscope: 2018-03-29
• 05057056106007 - Panoramic Ophthalmoscope: 2018-03-29