FDA.reportPublic FDA data

VISCO(TM)360 Viscosurgical System

Primary DI
00858027006013
Brand
VISCO(TM)360 Viscosurgical System
Company
Sight Sciences, Inc.
Model
FG 03916
Device description
US version of the Visco360
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K132494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132494000VISCOELASTIC INJECTORSight Sciences, Inc.2013-10-22MRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858027006013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858027006013008580270060138580270060130858027006013

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic needle, single-useA slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles, or to an intraocular implant; it may also be intended for aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962750381
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858027006372OMNI(R) Surgical System (US)FG 067211-1022020-06-01
00858027006549TearCare MGX System - TearCare MGX Technology KitFG 087895-1182025-04-30
00858027006297TearCare MGX System - TearCare MGX SmartLidsFG 087855-1092025-04-29
00858027006594OMNI Edge Surgical System1-1122025-03-06
00858027006280TearCare SmartLid FG 061135-1052019-08-27
00858027006358OMNI PLUS1-1042020-10-30
00858027006433OMNI Surgical SystemFG 077581-1062023-10-17
00858027006389TearCare(R) Clearance Assistant PLUSFG 069505-1072023-08-22
00858027006266TearCare(R) Clearance Assistant - SterileFG 056425-1042018-04-23
00858027006525OMNI Surgical SystemFG 074411-1082022-08-22
00858027006501Sion Surgical InstrumentFG 082551-1072022-08-01
00858027006457TearCare System - TearCare SmartHub KitFG 073925-1162022-03-03
00858027006495TearCare System - TearCare SmartLidsFG 079385-1172022-03-03
00858027006273TearCare(TM) (2.2) System KitFG 060415-1002019-08-27
10858027006256TearCare iLid (TM) Device Packaged Pair - 10 pkFG 056205-1012018-03-16
00858027006334OMNI Surgical System (US)FG 057571-1022019-10-25
00858027006112TRAB(TM)360 Trabeculotomy SystemFG 037062016-11-23
00858027006211TearCare SystemFG 050312017-02-01
00858027006228TearCare iLid PairFG 051182017-02-01
00858027006242TearCare(TM) System KitFG 055095-1002018-03-16

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
00893872001585ViscoInjectorNova Eye, Inc.MRH2019-01-28
00858027006310OMNI Surgical System (US)Sight Sciences, Inc.MRH2018-03-16
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