FDA.reportPublic FDA data

Head-Up-Display, HUD-1

Primary DI
00855005006218
Brand
Head-Up-Display, HUD-1
Company
TOPCON MEDICAL LASER SYSTEMS, INC.
Model
Head-Up-Display,HUD-1
Catalog number
SA-06427
Device description
Head-Up-Display, HUD-1, Ophthalmic Projector
Published
2018-02-12
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOSProjector, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855005006218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855005006218008550050062188550050062180855005006218

GMDN Terms#

Term, Definition table
TermDefinition
Image display monitor, colourA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, used for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This GMDN code is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)850-1223tmlsservice@topcon.com

Regulatory Flags#

DUNS number
041376321
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855005006102PASCAL Laser Indirect OphthalmoscopeLIO for Streamline 532SA-061612016-04-15
00855005006119PASCAL Laser Indirect OphthalmoscopeLIO for Streamline 577SA-061622016-04-15
00855005006126PASCAL Laser Indirect OphthalmoscopeLIO for Synthesis 532SA-061712016-04-15
00855005006133PASCAL Laser Indirect OphthalmoscopeLIO for Synthesis 577SA-061722016-04-15
00855005006140PASCAL Laser Indirect OphthalmoscopeLIO for PASCAL Photocoagulator 532SA-062012016-04-15
00855005006232PASCAL Synthesis TwinStarPASCAL Synthesis TwinStar (577/638)- PA04SA-064522019-09-17
00855005006249PACSAL SynthesisPASCAL Synthesis 532- PA04SA-064542019-09-17
00855005006256PASCAL SynthesisPASCAL Synthesis 577- PA04SA-064552019-09-17
00855005006263PASCAL Synthesis TwinStarPASCAL Synthesis TwinStar (577/638)- PA04SA-064532019-09-17
00855005006270PACSAL SynthesisPASCAL Synthesis 532- PA04SA-064562019-09-17
00855005006287PACSAL SynthesisPASCAL Synthesis 577- PA04SA-064572019-09-17
00855005006003PASCAL SynthesisPASCAL Synthesis 532SA-062802016-04-15
00855005006010PASCAL SynthesisPASCAL Synthesis 577SA-062812016-04-15
00855005006027PASCAL SynthesisPASCAL Synthesis 532SA-062842016-04-15
00855005006034PASCAL SynthesisPASCAL Synthesis 577SA-062852016-04-15
00855005006041PASCAL SynthesisSynthesis SLC & ESF 532SA-063762016-04-15
00855005006058PASCAL SynthesisSynthesis SLC & ESF 577SA-063772016-04-15
00855005006065PASCAL SynthesisSynthesis SLC & ESF 532SA-061952016-04-15
00855005006072PASCAL SynthesisSynthesis SLC & ESF 577SA-061972016-04-15
00855005006089PASCAL SynthesisSynthesis SLC & ESF 532SA-061942016-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03615020000113CP 550ESSILOR INTERNATIONALHOS2026-02-23
00850053428500VisiChartTOPCON HEALTHCARE INCHOS2023-06-20
04560323640902TAKAGITAKAGI SEIKO CO.,LTD.HOS2023-06-09
04562123289206AUTO CHART PROJECTOR ACP-8TOPCON CORPORATIONHOS2022-08-31
00850040295016M&S Technologies VisiChart® Acuity ChartThe Hilsinger Company Parent LLCHOS2022-07-06
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 LLCHOS2022-07-06
00850040295214M&S Technologies Melbourne Rapid Fields Device In-ClinicThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295351M&S Technologies ACUITYexThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295559M&S Technologies Smart System® StandardThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295047M&S Technologies Smart System® 20/20The Hilsinger Company Parent LLCHOS2022-07-06
00850040295191M&S Technologies Smart System® PC-PlusThe Hilsinger Company Parent LLCHOS2022-07-06
00850040295108M&S Technologies Smart System® 20/20 TabletThe Hilsinger Company Parent LLCHOS2022-07-06
00813125016838Head-Up-Display, HUD-1IRIDEX CORPORATIONHOS2021-12-05
08809358430314Medizs Auto Chart Projector CP-11MEDIZS Inc.HOS2021-03-23
06971821404015Auto chart projectorNingbo Ming Sing Optical R & D Co., Ltd.HOS2020-08-05
08800019600220Chart Projector CCP-3100Huvitz Co., Ltd.HOS2019-05-10
08800019600237Chart Projector HCP-7000Huvitz Co., Ltd.HOS2019-05-10
06945033902058TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HOS2018-09-24
06945033902065TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HOS2018-09-24