FDA.reportPublic FDA data

M&S Technologies ACUITYex

Primary DI
00850040295351
Brand
M&S Technologies ACUITYex
Company
The Hilsinger Company Parent LLC
Model
EX-100
Device description
M&S Technologies ACUITYex
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
00850040295351PackageGS11In Commercial Distribution
00850040295238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040295351008500402953518500402953510850040295351
00850040295238008500402952388500402952380850040295238

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
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
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
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
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