RTVue XR Avanti Scanner 500-50845-003

GUDID 00858848006667

For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System

OPTOVUE, INC.

Spectral-domain optical coherence tomography system

• Primary Device ID: 00858848006667
• NIH Device Record Key: 5f3f018d-2a13-428c-8ae4-c6a383a1762b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RTVue XR Avanti Scanner
• Version Model Number: Avanti Scanner
• Catalog Number: 500-50845-003
• Company DUNS: 196500461
• Company Name: OPTOVUE, INC.
• 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

Customer Support Contacts

• Phone: 866-941-9240
• Email: service@optovue.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858848006667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153080

FDA Product Code

• HLI: Ophthalmoscope, Ac-Powered

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: 2019-06-20
• Device Publish Date: 2019-06-12

On-Brand Devices [RTVue XR Avanti Scanner]

• 00858848006377: For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System
• 00858848006360: For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System
• 00858848006353: For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System
• 00858848006667: For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System