FDA.reportPublic FDA data

TOTOKU

Primary DI
04996005103043
Brand
TOTOKU
Company
JVC KENWOOD CORPORATION
Model
MS25i2/N
Device description
2MP Monochrome LCD Monitor ML21025-B0D0U
Published
2016-08-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K13351100021.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)Jvckenwood Corporation2013-12-19LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04996005103043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04996005103043049960051030434996005103043

GMDN Terms#

Term, Definition table
TermDefinition
Image display monitor, monochromeA 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 only one text/image colour, e.g., measured values or images from other devices. The information displayed will be limited (the view will become confusing to the user when too much information is shown). A keyboard may be connected for interactive manipulation of the data by the user. This GMDN code is the product identifier for the monitor only and does 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

Regulatory Flags#

DUNS number
713321040
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00046838501111JVCCL-S3012024-08-19
00046838002687JVCCL-R8132023-01-05
00046838076350JVCCCL358i2/N2017-04-01
00046838076367JVCCCL358i2/F2017-04-01
00046838076374JVCCCL550i2/N2017-04-01
00046838076381JVCCCL550i2/F2017-04-01
00046838076411JVCMS55i2 plus2017-09-01
00046838076435JVCMS55i2 plus2017-09-01
00046838076510JVCMS35i2/F2017-05-01
00046838076527JVCMS35i2/N2017-05-01
00046838076534JVCMS35i2/AR2017-05-01
00046838076541JVCMS25i2/F2017-05-01
00046838076558JVCMS25i2/N2017-05-01
00046838076565JVCMS25i2/AR2017-05-01
00046838076572JVCCCL258i2/N2017-05-01
00046838076589JVCCCL258i2/AR2017-05-01
00046838076596JVCCCL258i2/F2017-05-01
00046838076602JVCCCL650i2/N2017-05-01
00046838076619JVCCCL650i2/AR2017-05-01
00046838076626JVCCCL2142017-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22
B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
00850631008926Roentgen WorksBrit Systems, LLCLLZ2026-10-21
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20