FDA.reportPublic FDA data

iTrack Advance

Primary DI
00893872001622
Brand
iTrack Advance
Company
Nova Eye, Inc.
Model
iTrack-ADS
Catalog number
203000-0001
Device description
Canaloplasty Microcatheter Kit with Advanced Delivery SystemKit Contents(1) Canaloplasty Microcatheter with Delivery System(2) Ophthalmic ViscoInjector
Published
2023-04-04
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
HMXCannula, Ophthalmic
MPAEndoilluminator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1
MPAEndoilluminatorGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221872000ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical)2023-03-30MPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00893872001622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00893872001622008938720016228938720016220893872001622

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-useA hand-held ophthalmic surgical instrument with a thin, rigid insertion portion designed to infuse, irrigate and/or aspirate the interior of the eye during a surgical procedure (e.g., cataract extraction), and simultaneously conduct, typically via a fibreoptic bundle, a field of cold light to illuminate the surgical site. It is connected to a light source (through a light cable) and to appropriate devices that provide the infusion/aspiration function. It is typically made of high-grade stainless steel and fibreoptic materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length45Millimeter
Outer Diameter250Micrometer

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry location at room temperature
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-510-291-1300iTrack@nova-eye.com
1-510-291-1300info@nova-eye.com

Regulatory Flags#

DUNS number
079755637
Device count
1
Kit
true
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
00893872001059iTrack 250AiTrack 250A2004782016-09-15
00893872001073iLuminFI-1002005292016-09-15
00893872001585ViscoInjectorViscoInjector2020382019-01-28
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
00860015282040Intrace USAPILOTIS TECH LLCHMX2026-07-03
00840285320796Walcott Rx ProductsWalcott Rx Product IncHMX2026-06-26
00840319759189Hayden MedicalHayden Medical, Inc.HMX2026-06-24
04251047903151Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047903175Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047903632Chang Phaco ChopperA1 Medical GmbHHMX2026-06-09
04251047903755Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047915086Akahoshi Combo Pre-ChopperA1 Medical GmbHHMX2026-05-29
04251047923296Rycroft Air Injection CannulaA1 Medical GmbHHMX2026-05-29
04251047923388Sauter Hydrodissection CannulaA1 Medical GmbHHMX2026-05-29
04251047933295Gerten Clear Cornea DALK CannulaA1 Medical GmbHHMX2026-05-29
04251047934520Gerten Easy Liquid Bubble DMEK CannulaA1 Medical GmbHHMX2026-05-29
08600088329110Maskin MG Probe 1mmMGD INNOVATIONS, LLCHMX2026-05-07
G22312643590Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G223140461200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G346EEC0330Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMX2026-03-18
G22312624110Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2025-09-10
07612717072091FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-26
07612717072107FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-26
07612717072060FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-25
07612717072077FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-25
08052276019639Silicone Oil Infusion Line 23G for TocarAKTIVE SRLHMX2024-01-11
08052276019646Silicone Oil Infusion Line 25G for TrocarAKTIVE SRLHMX2024-01-11
08052276019653Infusion Line Silicone 20G 4mm for Trocar universalAKTIVE SRLHMX2024-01-11
08052276020079Infusion Cannula 20G, 2,5 mm AKTIVE SRLHMX2024-01-11
08052276020093Infusion Cannula 20G, 4,0 mm AKTIVE SRLHMX2024-01-11
08052276020109Infusion Cannula 20G, 6,0 mm AKTIVE SRLHMX2024-01-11
08052276020116Silicone Oil Infusion Cannula 20G, 4,0mm AKTIVE SRLHMX2024-01-11
08052276020123Silicone Oil Infusion Cannula 20G, 6mm AKTIVE SRLHMX2024-01-11
08052276026743Subretinal injection needle 23G tapered to 38G complete with handpieceAKTIVE SRLHMX2024-01-11