Box for radiographic Grid-1000(11"x13"(outside 395mmx380mm))

GUDID 08809413810273

A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" are filled with aluminium (Al) or another x-ray transparent (radiolucent) organic compound. Radiographic grids are placed between the x-ray target (patient) and the x-ray film and are used to absorb scatter radiation, and improve radiographic image contrast. It typically comes in two patterns, linear and crossed. Most are focused to a line in space called a convergent line, but can be used over a variable range called the focal distance.

JPI HEALTHCARE. CO., LTD.

Stationary x-ray grid

• Primary Device ID: 08809413810273
• NIH Device Record Key: cbc1da61-604e-4d31-a1be-172383e01660
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Box for radiographic Grid-1000(11"x13"(outside 395mmx380mm))
• Version Model Number: Grid-1000
• Company DUNS: 687797852
• Company Name: JPI HEALTHCARE. CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 516 513-1330
• Email: cust.serv@jpihealthcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809413810273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945327

FDA Product Code

• IXJ: Grid, Radiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-04
• Device Publish Date: 2020-02-25

Devices Manufactured by JPI HEALTHCARE. CO., LTD.

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• 08809413810273 - Box for radiographic Grid-1000(11"x13"(outside 395mmx380mm)): 2020-03-04A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" are filled with aluminium (Al) or another x-ray transparent (radiolucent) organic compound. Radiographic grids are placed between the x-ray target (patient) and the x-ray film and are used to absorb scatter radiation, and improve radiographic image contrast. It typically comes in two patterns, linear and crossed. Most are focused to a line in space called a convergent line, but can be used over a variable range called the focal distance.
• 08809413810273 - Box for radiographic Grid-1000(11"x13"(outside 395mmx380mm)): 2020-03-04 A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging. It typically consists