FDA.reportPublic FDA data

M&S Technologies Clinical Trial Suite®

Primary DI
00850040295139
Brand
M&S Technologies Clinical Trial Suite®
Company
The Hilsinger Company Parent LLC
Model
CTS-1500-HR
Device description
M&S Technologies Clinical Trial Suite®
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
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
00850040295009PackageGS11In Commercial Distribution
00850040295153PackageGS11In Commercial Distribution
00850040295160PackageGS11In Commercial Distribution
00850040295757PackageGS11In Commercial Distribution
00850040295764PackageGS11In Commercial Distribution
00850040295771PackageGS11In Commercial Distribution
00850040295139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040295009008500402950098500402950090850040295009
00850040295153008500402951538500402951530850040295153
00850040295160008500402951608500402951600850040295160
00850040295757008500402957578500402957570850040295757
00850040295764008500402957648500402957640850040295764
00850040295771008500402957718500402957710850040295771
00850040295139008500402951398500402951390850040295139

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
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
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
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
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
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
00850040295047M&S Technologies Smart System® 20/20The Hilsinger Company Parent LLCQTO2022-07-06
00850040295047M&S Technologies Smart System® 20/20The Hilsinger Company Parent LLCHOS2022-07-06
00850040295191M&S Technologies Smart System® PC-PlusThe Hilsinger Company Parent LLCQTO2022-07-06