iStand 700-48491-001

GUDID 00858848006285

iStand 2

OPTOVUE, INC.

Ophthalmic stand, electric

• Primary Device ID: 00858848006285
• NIH Device Record Key: afd5eb1d-8eca-4e65-b83c-b40075d99661
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iStand
• Version Model Number: iStand
• Catalog Number: 700-48491-001
• 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
• Phone: 866-941-9240
• Email: service@optovue.com
• Phone: 866-941-9240
• Email: service@optovue.com
• Phone: 866-941-9240
• Email: service@optovue.com
• Phone: 866-941-9240
• Email: service@optovue.com
• Phone: 866-941-9240
• Email: service@optovue.com
• Phone: 866-941-9240
• Email: service@optovue.com
• Phone: 866-941-9240
• Email: service@optovue.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858848006285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103266

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-03

Devices Manufactured by OPTOVUE, INC.

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• 00858848006728 - RTVue XR Avanti: 2020-02-11 Ophthalmic Optical Coherence Tomography System with 100/240V Table
• 00858848006704 - RTVue XR Avanti: 2019-09-30 Ophthalmic Optical Coherence Tomography System with 100/240V Table
• 00858848006667 - RTVue XR Avanti Scanner: 2019-06-20 For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System