FDA.reportPublic FDA data

Optik View

Primary DI
00819761022943
Brand
Optik View
Company
LINDEN GROUP CORPORATION, THE
Model
SC31813
Device description
"31"" SC31813 - Medical monitor"
Published
2023-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQMCamera, Surgical And Accessories
PGYDisplay, Diagnostic Radiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1
PGYDisplay, Diagnostic RadiologyRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819761022943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819761022943008197610229438197610229430819761022943

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed 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 group of devices 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9739838809bob@tlgc.com
973-983-8809support@tlgc.com
9739838809duane_brikowski@tlgc.com

Regulatory Flags#

DUNS number
962898052
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819761023117Optik ViewSC6583522026-06-25
00819761023124Optik ViewSC6583532026-06-25
00819761023063Optik ViewSC4384402026-06-05
00819761023087Optik ViewSC6583512026-06-05
00819761023094Optik ViewSC5584422026-06-04
00819761023032Optik ViewSC6583512025-11-25
00819761023049Optik ViewSC5584432025-11-24
00819761022929Optik ViewSC278102023-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04995047069300RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047069362RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072676RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072683RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072843RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072904RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072935RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047072973RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073055RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073185RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073208RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073277RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073338RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073376RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073444RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073468RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073475RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073611RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073673RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073703RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073819RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073871RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047073895RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074311RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074373RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074441RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074588RadiForce®EIZO CORPORATIONPGY2026-07-22
04995047074601RadiForce®EIZO CORPORATIONPGY2026-07-22
10197344213627MEDLINEMEDLINE INDUSTRIES, INC.KQM2026-07-20
08809241513148CW60NWIDE corporationPGY2026-07-16