OCT Ophthalmoscope A10750

GUDID 05057056107509

A desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and targeted navigated optical coherence tomography.

OPTOS PUBLIC LIMITED COMPANY

Scanning-laser ophthalmoscope/retinal optical coherence tomography system

• Primary Device ID: 05057056107509
• NIH Device Record Key: e22328b6-592c-42a3-98c4-5c5b8c40ed35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCT Ophthalmoscope
• Version Model Number: P200TxE
• Catalog Number: A10750
• 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: 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 683 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05057056107509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190732

FDA Product Code

• MYC: Ophthalmoscope, Laser, Scanning

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: 2019-11-06
• Device Publish Date: 2019-10-29

On-Brand Devices [OCT Ophthalmoscope ]

• 05057056107004: The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer inte
• 05057056107509: A desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy