FDA.reportPublic FDA data

M&S Technologies Smart System® 20/20

Primary DI
00850040295047
Brand
M&S Technologies Smart System® 20/20
Company
The Hilsinger Company Parent LLC
Model
Smart System 20/20
Device description
M&S Technologies Smart System® 20/20
Published
2022-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOSProjector, Ophthalmic
QTODigital Visual Acuity Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOSProjector, OphthalmicOphthalmic1
QTODigital Visual Acuity TestOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040295023PackageGS11In Commercial Distribution
00850040295030PackageGS11In Commercial Distribution
00850040295047PackageGS11In Commercial Distribution
00850040295054PackageGS11In Commercial Distribution
00850040295092PackageGS11In Commercial Distribution
00850040295221PackageGS11In Commercial Distribution
00850040295245PackageGS11In Commercial Distribution
00850040295269PackageGS11In Commercial Distribution
00850040295337PackageGS11In Commercial Distribution
00850040295344PackageGS11In Commercial Distribution
00850040295368PackageGS11In Commercial Distribution
00850040295375PackageGS11In Commercial Distribution
00850040295382PackageGS11In Commercial Distribution
00850040295399PackageGS11In Commercial Distribution
00850040295405PackageGS11In Commercial Distribution
00850040295412PackageGS11In Commercial Distribution
00850040295504PackageGS11In Commercial Distribution
00850040295511PackageGS11In Commercial Distribution
00850040295535PackageGS11In Commercial Distribution
00850040295610PackageGS11In Commercial Distribution
00850040295627PackageGS11In Commercial Distribution
00850040295634PackageGS11In Commercial Distribution
00850040295658PackageGS11In Commercial Distribution
00850040295672PackageGS11In Commercial Distribution
00850040295696PackageGS11In Commercial Distribution
00850040295702PackageGS11In Commercial Distribution
00850040295719PackageGS11In Commercial Distribution
00850040295788PackageGS11In Commercial Distribution
00850040295566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040295023008500402950238500402950230850040295023
00850040295030008500402950308500402950300850040295030
00850040295047008500402950478500402950470850040295047
00850040295054008500402950548500402950540850040295054
00850040295092008500402950928500402950920850040295092
00850040295221008500402952218500402952210850040295221
00850040295245008500402952458500402952450850040295245
00850040295269008500402952698500402952690850040295269
00850040295337008500402953378500402953370850040295337
00850040295344008500402953448500402953440850040295344
00850040295368008500402953688500402953680850040295368
00850040295375008500402953758500402953750850040295375
00850040295382008500402953828500402953820850040295382
00850040295399008500402953998500402953990850040295399
00850040295405008500402954058500402954050850040295405
00850040295412008500402954128500402954120850040295412
00850040295504008500402955048500402955040850040295504
00850040295511008500402955118500402955110850040295511
00850040295535008500402955358500402955350850040295535
00850040295610008500402956108500402956100850040295610
00850040295627008500402956278500402956270850040295627
00850040295634008500402956348500402956340850040295634
00850040295658008500402956588500402956580850040295658
00850040295672008500402956728500402956720850040295672
00850040295696008500402956968500402956960850040295696
00850040295702008500402957028500402957020850040295702
00850040295719008500402957198500402957190850040295719
00850040295788008500402957888500402957880850040295788
00850040295566008500402955668500402955660850040295566

GMDN Terms#

Term, Definition table
TermDefinition
Visual acuity projectorA mains electricity (AC-powered) ophthalmic device intended to project an image on a screen to test visual acuity. The images typically include block letters (Snellen chart) and/or other symbols (e.g., recognizable objects used for children who cannot read) viewed in gradually decreasing size. They are typically identified according to the distance at which they are ordinarily visible (normally 6 metres or 20 feet).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-225-6101techsupport@mstech-eyes.com

Regulatory Flags#

DUNS number
118021111
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040295818OCULUS Easyfield VROCVR-012023-12-25
00850040295238M&S Technologies ACUITYexEX-1002022-07-06
00850040295566M&S Technologies Smart System® 20/20Smart System 20/202022-07-06
00850040295573M&S Technologies Smart System® PC-PlusSmart System PC-Plus2022-07-06
00850040295597M&S Technologies Smart System® 20/20 TabletSmart System 20/20 Tablet2022-07-06
00850040295016M&S Technologies VisiChart® Acuity Chart12034CRP12034CRP2022-07-06
00850040295122M&S Technologies Smart System® Virtual Reality Headset SystemVR-1002H2022-07-06
00850040295139M&S Technologies Clinical Trial Suite®CTS-1500-HR2022-07-06
00850040295214M&S Technologies Melbourne Rapid Fields Device In-ClinicMRF-001-22022-07-06
00850040295559M&S Technologies Smart System® StandardSmart System Standard2022-07-06
00850040295351M&S Technologies ACUITYexEX-1002022-07-06
00850040295191M&S Technologies Smart System® PC-PlusSmart System PC-Plus2022-07-06
00850040295108M&S Technologies Smart System® 20/20 TabletSmart System 20/20 Tablet2022-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850067216025Manifold Vision MeterAdaptive Sensory Technology, Inc.QTO2026-05-21
00850067216032Manifold Vision MeterAdaptive Sensory Technology, Inc.QTO2026-05-21
03615020000113CP 550ESSILOR INTERNATIONALHOS2026-02-23
00850067216001Manifold Vision MeterAdaptive Sensory Technology, Inc.QTO2025-10-07
00850067216018Manifold Vision MeterAdaptive Sensory Technology, Inc.QTO2025-10-07
00850040295818OCULUS Easyfield VRThe Hilsinger Company Parent LLCQTO2023-12-25
07290018993408MyRx Visual Acuity 6 OVER 6 VISION LTDQTO2023-08-30
00853569007146PalmScan VS2000Micro Medical Devices, Inc.QTO2023-08-16
G506DG010AMA Optics Digital Vision TestAMA Optics, Inc.QTO2023-08-01
00850053428500VisiChartTOPCON HEALTHCARE INCHOS2023-06-20
04560323640902TAKAGITAKAGI SEIKO CO.,LTD.HOS2023-06-09
00850038376000VDAPVisibly, Inc.QTO2022-09-19
04562123289206AUTO CHART PROJECTOR ACP-8TOPCON CORPORATIONHOS2022-08-31
00850040295238M&S Technologies ACUITYexThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295566M&S Technologies Smart System® 20/20The Hilsinger Company Parent LLCQTO2022-07-06
00850040295573M&S Technologies Smart System® PC-PlusThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295597M&S Technologies Smart System® 20/20 TabletThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295016M&S Technologies VisiChart® Acuity ChartThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295016M&S Technologies VisiChart® Acuity ChartThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295122M&S Technologies Smart System® Virtual Reality Headset SystemThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295122M&S Technologies Smart System® Virtual Reality Headset SystemThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295139M&S Technologies Clinical Trial Suite®The Hilsinger Company Parent LLCQTO2022-07-06
00850040295139M&S Technologies Clinical Trial Suite®The Hilsinger Company Parent LLCHOS2022-07-06
00850040295214M&S Technologies Melbourne Rapid Fields Device In-ClinicThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295214M&S Technologies Melbourne Rapid Fields Device In-ClinicThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295351M&S Technologies ACUITYexThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295351M&S Technologies ACUITYexThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295559M&S Technologies Smart System® StandardThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295559M&S Technologies Smart System® StandardThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295191M&S Technologies Smart System® PC-PlusThe Hilsinger Company Parent LLCQTO2022-07-06