ViscoInjector 202038

GUDID 00893872001585

Opthalmic Viscoelastic Injector

Nova Eye, Inc.

General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: 00893872001585
• NIH Device Record Key: e5fd70bb-7ef3-4e1c-ac79-6eaede74b586
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViscoInjector
• Version Model Number: ViscoInjector
• Catalog Number: 202038
• 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
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com
• Phone: 1-510-291-1300
• Email: iTrack@nova-eye.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893872001585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050716

FDA Product Code

• MRH: Pump, Infusion, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-12-08
• Device Publish Date: 2019-01-28

Devices Manufactured by Nova Eye, Inc.

• 00893872001622 - iTrack Advance: 2023-04-12 Canaloplasty Microcatheter Kit with Advanced Delivery System Kit Contents (1) Canaloplasty Microcatheter with Delivery System (2
• 893872001462 - iCAP Imaging Cap: 2020-12-08 Imaging Cap
• 00893872001585 - ViscoInjector: 2020-12-08Opthalmic Viscoelastic Injector
• 00893872001585 - ViscoInjector: 2020-12-08 Opthalmic Viscoelastic Injector