AccessGUDID - DEVICE: FUJI IP CASSETTE CC (04547410211252)

GUDID

Device Identifier (DI) Information

Brand Name: FUJI IP CASSETTE CC
Version or Model: CC BWPB 35.4X35.4cm(14X14)
Catalog Number:
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410211252
Issuing Agency: GS1
Device Count: 1

Device Description: The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
General-purpose radiography digital imaging system	An assembly of devices that acquires and digitizes x-ray images for viewing, storage, or hard-copy printing. It is used in conjunction with conventional radiographic table systems for a variety of purposes. It typically consists of an exposure unit with imaging receptor (e.g., a cassette containing a plate), an image reader, a computer console, and a printer. The image is acquired on a photostimulatable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner; this signal is in turn amplified and converted to a digital signal, which is stored and processed by a computer.

GMDN Preferred Term Name

GMDN Definition

General-purpose radiography digital imaging system

An assembly of devices that acquires and digitizes x-ray images for viewing, storage, or hard-copy printing. It is used in conjunction with conventional radiographic table systems for a variety of purposes. It typically consists of an exposure unit with imaging receptor (e.g., a cassette containing a plate), an image reader, a computer console, and a printer. The image is acquired on a photostimulatable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner; this signal is in turn amplified and converted to a digital signal, which is stored and processed by a computer.

FDA Product Code

[?]

Product Code	Product Code Name
MQB	Solid state x-ray imager (flat panel/digital imager)

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 0 and 45 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 35.4X35.4 CM

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 16, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
14547410211259	5	04547410211252		In Commercial Distribution	box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: FUJI IP CASSETTE CC (04547410211252)