FDA.reportPublic FDA data

M&S Technologies Smart System® 20/20 Tablet

Primary DI
00850040295597
Brand
M&S Technologies Smart System® 20/20 Tablet
Company
The Hilsinger Company Parent LLC
Model
Smart System 20/20 Tablet
Device description
M&S Technologies Smart System® 20/20 Tablet
Published
2022-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QTODigital Visual Acuity Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTODigital Visual Acuity TestOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040295108PackageGS11In Commercial Distribution
00850040295115PackageGS11In Commercial Distribution
00850040295306PackageGS11In Commercial Distribution
00850040295313PackageGS11In Commercial Distribution
00850040295542PackageGS11In Commercial Distribution
00850040295597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040295108008500402951088500402951080850040295108
00850040295115008500402951158500402951150850040295115
00850040295306008500402953068500402953060850040295306
00850040295313008500402953138500402953130850040295313
00850040295542008500402955428500402955420850040295542
00850040295597008500402955978500402955970850040295597

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).

Contacts#

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

Regulatory Flags#

DUNS number
118021111
Device count
1
Premarket exempt
true

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
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
00850040295047M&S Technologies Smart System® 20/20Smart System 20/202022-07-06
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
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
00850038376000VDAPVisibly, Inc.QTO2022-09-19
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
00850040295016M&S Technologies VisiChart® Acuity ChartThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295122M&S Technologies Smart System® Virtual Reality Headset SystemThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295139M&S Technologies Clinical Trial Suite®The Hilsinger Company Parent LLCQTO2022-07-06
00850040295214M&S Technologies Melbourne Rapid Fields Device In-ClinicThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295351M&S Technologies ACUITYexThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295559M&S Technologies Smart System® StandardThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295047M&S Technologies Smart System® 20/20The Hilsinger Company Parent LLCQTO2022-07-06
00850040295191M&S Technologies Smart System® PC-PlusThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295108M&S Technologies Smart System® 20/20 TabletThe Hilsinger Company Parent LLCQTO2022-07-06