FDA.reportPublic FDA data

M&S Technologies Smart System® PC-Plus

Primary DI
00850040295191
Brand
M&S Technologies Smart System® PC-Plus
Company
The Hilsinger Company Parent LLC
Model
Smart System PC-Plus
Device description
M&S Technologies Smart System® PC-Plus
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
00850040295061PackageGS11In Commercial Distribution
00850040295078PackageGS11In Commercial Distribution
00850040295177PackageGS11In Commercial Distribution
00850040295184PackageGS11In Commercial Distribution
00850040295191PackageGS11In Commercial Distribution
00850040295207PackageGS11In Commercial Distribution
00850040295276PackageGS11In Commercial Distribution
00850040295283PackageGS11In Commercial Distribution
00850040295290PackageGS11In Commercial Distribution
00850040295320PackageGS11In Commercial Distribution
00850040295429PackageGS11In Commercial Distribution
00850040295436PackageGS11In Commercial Distribution
00850040295443PackageGS11In Commercial Distribution
00850040295450PackageGS11In Commercial Distribution
00850040295474PackageGS11In Commercial Distribution
00850040295528PackageGS11In Commercial Distribution
00850040295641PackageGS11In Commercial Distribution
00850040295665PackageGS11In Commercial Distribution
00850040295726PackageGS11In Commercial Distribution
00850040295733PackageGS11In Commercial Distribution
00850040295740PackageGS11In Commercial Distribution
00850040295573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040295061008500402950618500402950610850040295061
00850040295078008500402950788500402950780850040295078
00850040295177008500402951778500402951770850040295177
00850040295184008500402951848500402951840850040295184
00850040295191008500402951918500402951910850040295191
00850040295207008500402952078500402952070850040295207
00850040295276008500402952768500402952760850040295276
00850040295283008500402952838500402952830850040295283
00850040295290008500402952908500402952900850040295290
00850040295320008500402953208500402953200850040295320
00850040295429008500402954298500402954290850040295429
00850040295436008500402954368500402954360850040295436
00850040295443008500402954438500402954430850040295443
00850040295450008500402954508500402954500850040295450
00850040295474008500402954748500402954740850040295474
00850040295528008500402955288500402955280850040295528
00850040295641008500402956418500402956410850040295641
00850040295665008500402956658500402956650850040295665
00850040295726008500402957268500402957260850040295726
00850040295733008500402957338500402957330850040295733
00850040295740008500402957408500402957400850040295740
00850040295573008500402955738500402955730850040295573

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
00850040295047M&S Technologies Smart System® 20/20Smart System 20/202022-07-06
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
00850040295047M&S Technologies Smart System® 20/20The Hilsinger Company Parent LLCQTO2022-07-06