iCAP Imaging Cap 200549

GUDID 893872001462

Imaging Cap

Nova Eye, Inc.

Cable/lead/sensor/probe cover, sterile Cable/lead/sensor/probe cover, sterile Cable/lead/sensor/probe cover, sterile Cable/lead/sensor/probe cover, sterile Cable/lead/sensor/probe cover, sterile Cable/lead/sensor/probe cover, sterile Cable/lead/sensor/probe cover, sterile Cable/lead/sensor/probe cover, sterile Cable/lead/sensor/probe cover, sterile Cable/lead/sensor/probe cover, sterile Cable/lead/sensor/probe cover, sterile Cable/lead/sensor/probe cover, sterile Cable/lead/sensor/probe cover, sterile Cable/lead/sensor/probe cover, sterile

• Primary Device ID: 893872001462
• NIH Device Record Key: aac518e9-bf29-4a60-bef4-27c2721d9fc8
• Commercial Distribution Discontinuation: 2017-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: iCAP Imaging Cap
• Version Model Number: IC-100
• Catalog Number: 200549
• Company DUNS: 079755637
• Company Name: Nova Eye, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 1-888-846-4724
• Email: canaloplasty@ellex.com
• Phone: 1-888-846-4724
• Email: canaloplasty@ellex.com
• Phone: 1-888-846-4724
• Email: canaloplasty@ellex.com
• Phone: 1-888-846-4724
• Email: canaloplasty@ellex.com
• Phone: 1-888-846-4724
• Email: canaloplasty@ellex.com
• Phone: 1-888-846-4724
• Email: canaloplasty@ellex.com
• Phone: 1-888-846-4724
• Email: canaloplasty@ellex.com
• Phone: 1-888-846-4724
• Email: canaloplasty@ellex.com
• Phone: 1-888-846-4724
• Email: canaloplasty@ellex.com
• Phone: 1-888-846-4724
• Email: canaloplasty@ellex.com
• Phone: 1-888-846-4724
• Email: canaloplasty@ellex.com
• Phone: 1-888-846-4724
• Email: canaloplasty@ellex.com
• Phone: 1-888-846-4724
• Email: canaloplasty@ellex.com
• Phone: 1-888-846-4724
• Email: canaloplasty@ellex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893872001028 [Primary]
GS1	893872001462 [Package]; Contains: 00893872001028; Package: Multiple Unit Box [15 Units]; Discontinued: 2017-11-30; Not in Commercial Distribution

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-12-08
• Device Publish Date: 2016-09-19

Devices Manufactured by Nova Eye, Inc.

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• 893872001462 - iCAP Imaging Cap: 2020-12-08Imaging Cap
• 893872001462 - iCAP Imaging Cap: 2020-12-08 Imaging Cap
• 00893872001585 - ViscoInjector: 2020-12-08 Opthalmic Viscoelastic Injector