ViscoInjector 202038

GUDID 00893872001585

Opthalmic Viscoelastic Injector

Nova Eye, Inc.

General-purpose syringe, single-use
Primary Device ID00893872001585
NIH Device Record Keye5fd70bb-7ef3-4e1c-ac79-6eaede74b586
Commercial Distribution StatusIn Commercial Distribution
Brand NameViscoInjector
Version Model NumberViscoInjector
Catalog Number202038
Company DUNS079755637
Company NameNova Eye, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-888-846-4724
Emailcanaloplasty@ellex.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com
Phone1-510-291-1300
EmailiTrack@nova-eye.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100893872001585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRHPump, Infusion, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-12-08
Device Publish Date2019-01-28

Devices Manufactured by Nova Eye, Inc.

00893872001608 - iLumin2024-07-29 Optical Light Source: Fiberoptic Illuminator, Gen 2 iLumin series of revisions
00893872001622 - iTrack Advance2023-04-12 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 - ViscoInjector2020-12-08Opthalmic Viscoelastic Injector
00893872001585 - ViscoInjector2020-12-08 Opthalmic Viscoelastic Injector

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