NA

Basic Information

• Brand Name: NA
• Primary DI: 04589607250019
• Version / Model: YS-3GA
• Company Name: YOSHIDA DENZAI KOGYO CO., LTD.
• Labeler DUNS: 690971676
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-13
• Public Version: 3
• Public Version Date: 2024-06-21
• Public Version Status: Update
• Public Device Record Key: cdecc741-1e1a-45e0-b864-b9887b12d761
• Distribution End Date: 2023-11-08

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPW	Device, Beam Limiting, X-Ray, Diagnostic	Radiology	892.1610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42253	Manual-aperture-control diagnostic x-ray system collimator, non-motorized	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04589607250019	GS1

Device Sizes

Type	Value	Unit	Text
Weight	8.5	Kilogram
Depth	227	Millimeter
Width	316	Millimeter
Height	277	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 120 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 60 – 100 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 5 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 69 – 106 KiloPascal