SCANLY 910-0001

GUDID 07290017803012

Home Monitoring Ophthalmic Optical Coherence Tomography (OCT) Imaging Device

NOTAL VISION LTD

Retinal optical coherence tomography system

• Primary Device ID: 07290017803012
• NIH Device Record Key: b1a36a14-5825-4b2e-a6cd-4879b5203dab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCANLY
• Version Model Number: 01.01
• Catalog Number: 910-0001
• Company DUNS: 532596533
• Company Name: NOTAL VISION LTD
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07290017803012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN230043

FDA Product Code

• SAX: Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

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: 2024-06-26
• Device Publish Date: 2024-06-18

On-Brand Devices [SCANLY]

• 07290017803012: Home Monitoring Ophthalmic Optical Coherence Tomography (OCT) Imaging Device
• 07290017803029: Home Monitoring Ophthalmic Optical Coherence Tomography (OCT) Imaging Device