Panoramic Ophthalmoscope A1021

GUDID 05057056010212

OPTOS PUBLIC LIMITED COMPANY

Scanning-laser ophthalmic imaging system

• Primary Device ID: 05057056010212
• NIH Device Record Key: 8e519dec-2581-41e8-9835-b130e23a43f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panoramic Ophthalmoscope
• Version Model Number: P200
• Catalog Number: A1021
• 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

Customer Support Contacts

• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com
• Phone: +4401383843347
• Email: lmichie@optos.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 0.5 KiloPascal and 1.06 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05057056010212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983999

FDA Product Code

• HLI: Ophthalmoscope, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-05-27

On-Brand Devices [Panoramic Ophthalmoscope]

• 05057056106502: P200DTx
• 05057056106007: P200T
• 05057056100210: P200C
• 05057056010212: P200