FUJI IP CASSETTE PC

GUDID 14547410050001

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.

FUJIFILM CORPORATION

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Primary Device ID14547410050001
NIH Device Record Key420a48e4-d74f-4364-8792-8bcfc687779e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFUJI IP CASSETTE PC
Version Model NumberPC 25.2X30.3
Company DUNS713565195
Company NameFUJIFILM CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx

Device Dimensions

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Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 45 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 45 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 45 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 45 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 45 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 45 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 45 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 45 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 45 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 45 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 45 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 45 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 45 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104547410050004 [Primary]
GS114547410050001 [Package]
Contains: 04547410050004
Package: box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid state x-ray imager (flat panel/digital imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2016-09-16

On-Brand Devices [FUJI IP CASSETTE PC]

14547410050001The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image R
14547410049999The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image R
14547410049982The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image R

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