NA

Primary DI
04589607250019
Brand
NA
Company
YOSHIDA DENZAI KOGYO CO., LTD.
Model
YS-3GA
Published
2017-09-13
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
KPWDevice, Beam Limiting, X-Ray, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPWDevice, Beam Limiting, X-Ray, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589607250019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589607250019045896072500194589607250019

GMDN Terms#

Term, Definition table
TermDefinition
Manual-aperture-control diagnostic x-ray system collimator, non-motorizedA standard, non-motorized, diagnostic x-ray beam-limiting device whose aperture size/length/shutter assembly must be manually adjusted in order to match the size of the x-ray beam to the size of the x-ray cassette in use. It includes designs with manual controls that operate one or more shutter pairs and also designs that require the addition or removal of attachments or extensions that allow the operator to alter the size and shape of the exit beam from a cone or cylinder. An x-ray collimator is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth227Millimeter
Height277Millimeter
Weight8.5Kilogram
Width316Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure69 KiloPascal106 KiloPascal
Handling Environment Humidity5 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature60 Degrees Fahrenheit100 Degrees Fahrenheit
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690971676
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04987670101670X-ray beam limiting deviceCANON INC.KPW2017-04-11
04056869011554Collimator ML01 IISiemens Healthcare GmbHKPW2017-02-02
04056869011578Collimator AL02 II eLSiemens Healthcare GmbHKPW2016-10-23
08057737120015Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAKPW2016-09-24
08057737120114Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAKPW2016-09-24
08057737120213Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAKPW2016-09-24
08057737120312Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAKPW2016-09-24
08057737120411Philips Medical Systems DMCVILLA SISTEMI MEDICALI SPAKPW2016-09-24
40889978154117X-ray Beam Filter KitCARESTREAM HEALTH, INC.KPW2016-09-16
60889978154111X-ray Beam Filter KitCARESTREAM HEALTH, INC.KPW2016-09-16
08058776050141Ralco srlRALCO SRLKPW2016-08-05
08058776050158Ralco srlRALCO SRLKPW2016-08-05
08058776050189Ralco srlRALCO SRLKPW2016-08-05
08058776050011Ralco srlRALCO SRLKPW2016-08-04
08058776050028Ralco srlRALCO SRLKPW2016-08-04
08058776050066Ralco srlRALCO SRLKPW2016-08-04
08058776050073Ralco srlRALCO SRLKPW2016-08-04
08058776050097Ralco srlRALCO SRLKPW2016-08-04
08058776050103Ralco srlRALCO SRLKPW2016-08-04
08058776050134Ralco srlRALCO SRLKPW2016-08-04