ViscoInjector

Primary DI
00893872001585
Brand
ViscoInjector
Company
Nova Eye, Inc.
Model
ViscoInjector
Catalog number
202038
Device description
Opthalmic Viscoelastic Injector
Published
2019-01-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRHPump, Infusion, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRHPump, Infusion, OphthalmicGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050716000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050716000ISCIENCE SURGICAL VISCOINJECTORIscience Surgical Corporation2005-04-21MRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00893872001585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00893872001585008938720015858938720015850893872001585

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-846-4724canaloplasty@ellex.com
1-510-291-1300iTrack@nova-eye.com

Regulatory Flags#

DUNS number
079755637
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00893872001653iTrack 250EiT-250E2020392026-05-05
00893872001684iTrack AdvanceiTrack-ADS203001-00012026-04-15
00893872001660iLuminFI-2012050012026-01-09
00893872001608iLuminFI-2002050002024-07-19
00893872001622iTrack AdvanceiTrack-ADS203000-00012023-04-04
00893872001059iTrack 250AiTrack 250A2004782016-09-15
00893872001073iLuminFI-1002005292016-09-15
00893872001028iCAP Imaging Cap IC-1002005492016-09-19
893872001462iCAP Imaging Cap IC-1002005492016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00893872001653iTrack 250ENova Eye, Inc.MRH2026-05-05
00858027006594OMNI Edge Surgical SystemSight Sciences, Inc.MRH2025-03-06
00892064002362VIA360 Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2025-02-18
00892064002102Streamline Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2025-02-15
00892064002072Streamline Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2023-11-01
00858027006433OMNI Surgical SystemSight Sciences, Inc.MRH2023-10-17
00844685009381TrabEx ProMICROSURGICAL TECHNOLOGY, INC.MRH2022-09-22
00858027006525OMNI Surgical SystemSight Sciences, Inc.MRH2022-08-22
00853704002456iPRIMEGLAUKOS CORPORATIONMRH2022-05-13
00892064002010Streamline® Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2021-11-01
00858027006358OMNI PLUSSight Sciences, Inc.MRH2020-10-30
00858027006372OMNI(R) Surgical System (US)Sight Sciences, Inc.MRH2020-06-01
00858027006334OMNI Surgical System (US)Sight Sciences, Inc.MRH2019-10-25
00858027006310OMNI Surgical System (US)Sight Sciences, Inc.MRH2018-03-16
00858027006013VISCO(TM)360 Viscosurgical SystemSight Sciences, Inc.MRH2016-09-22
00893872001059iTrack 250ANova Eye, Inc.MRH2016-09-15
00853480006013Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14
00853480006242Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14
10853480006010Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14
10853480006249Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14