Avanti 700-48076-004

GUDID 00858848006001

RTVue XR System w/ CAM w/ 120V Table w/ 45pt Fixation

OPTOVUE, INC.

Spectral-domain optical coherence tomography system

• Primary Device ID: 00858848006001
• NIH Device Record Key: 986f2263-6c68-4551-92d8-68af25a7e910
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avanti
• Version Model Number: RTVue XR100-1
• Catalog Number: 700-48076-004
• 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	00858848006001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153080

FDA Product Code

• OBO: Tomography, Optical Coherence

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: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [Avanti]

• 00858848006032: Assy Scanner Integration w/CAM XR w/ 45pt Fixation
• 00858848006025: RTVue XR System w/ CAM w/ 230V Table w/ 45pt Fixation
• 00858848006001: RTVue XR System w/ CAM w/ 120V Table w/ 45pt Fixation