FDA.reportPublic FDA data

VIA360 Surgical System

Primary DI
00892064002362
Brand
VIA360 Surgical System
Company
NEW WORLD MEDICAL, INCORPORATED
Model
VIA360
Catalog number
10-0615
Device description
VIA360 Surgical System
Published
2025-02-18
Public version status
New
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
HMZTrabeculotome
MRHPump, infusion, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMZTrabeculotomeOphthalmic1
MRHPump, Infusion, OphthalmicGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243503000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243503000VIA360™ Surgical SystemNew World Medical, Inc.2025-02-14MRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00892064002362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00892064002362008920640023628920640023620892064002362

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic knife, single-useA hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ silicon (i.e., a brittle metalloid material) blades. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(909)466-4304orders@newworldmedical.com

Regulatory Flags#

DUNS number
622768711
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00892064002072Streamline Surgical System10-006610-00662023-11-01
00892064002089Ahmed ClearPath STST25010-06092024-12-18
00892064002096Ahmed ClearPath STST35010-06102024-12-18
00892064002355Ahmed™ ClearPath350CP3502019-01-23
00892064002188Ahmed™ Glaucoma ValveTETE2020-08-12
00892064002348Ahmed™ ClearPath250CP2502019-01-23
00892064002294Kahook Dual BladeKDBKDB2016-11-22
00892064002003Kahook Dual Blade GlideKDB Glide10-00652020-10-13
00892064002102Streamline Surgical System10-006610-00662025-02-15
00892064002010Streamline® Surgical System10-006610-00662021-11-01
00892064002126Ahmed™ Glaucoma ValveFP8FP82017-09-08
00892064002119Ahmed™ Glaucoma ValveFP7FP72016-11-16
00892064002331Ahmed Tube InserterTITI2018-10-11
00892064002133Ahmed™ Glaucoma ValveS2S22015-03-24
00892064002140Ahmed™ Glaucoma ValveS3S32015-03-24
00892064002270Ahmed™ Glaucoma ValveM4M42015-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00893872001653iTrack 250ENova Eye, Inc.MRH2026-05-05
00194613004057MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613007614MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613021061MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613021078MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613021085MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613111496MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613119362MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613120382MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00757770409761Bausch + LombBausch & Lomb IncorporatedHMZ2025-04-21
00194613004040MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-03-21
00194613084714MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-03-21
00858027006594OMNI Edge Surgical SystemSight Sciences, Inc.HMZ2025-03-06
00858027006594OMNI Edge Surgical SystemSight Sciences, Inc.MRH2025-03-06
00892064002102Streamline Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2025-02-15
00892064002072Streamline Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2023-11-01
00858027006433OMNI Surgical SystemSight Sciences, Inc.HMZ2023-10-17
00858027006433OMNI Surgical SystemSight Sciences, Inc.MRH2023-10-17
00844685009381TrabEx ProMICROSURGICAL TECHNOLOGY, INC.MRH2022-09-22
05055313811336Duckworth & KentDUCKWORTH AND KENT LIMITEDHMZ2022-08-31
05055313811343Duckworth & KentDUCKWORTH AND KENT LIMITEDHMZ2022-08-31
05055313811350Duckworth & KentDUCKWORTH AND KENT LIMITEDHMZ2022-08-31
00858027006525OMNI Surgical SystemSight Sciences, Inc.HMZ2022-08-22
00858027006525OMNI Surgical SystemSight Sciences, Inc.MRH2022-08-22
00858027006501Sion Surgical InstrumentSight Sciences, Inc.HMZ2022-08-01
00853704002456iPRIMEGLAUKOS CORPORATIONMRH2022-05-13
00892064002010Streamline® Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2021-11-01
00858027006358OMNI PLUSSight Sciences, Inc.HMZ2020-10-30
00858027006358OMNI PLUSSight Sciences, Inc.MRH2020-10-30
00858027006372OMNI(R) Surgical System (US)Sight Sciences, Inc.HMZ2020-06-01