ORTHO CP-GU M 55BHW

GUDID 05414904220863

AGFA

Medical x-ray film, screen
Primary Device ID05414904220863
NIH Device Record Key76b48408-9957-44b5-930e-741dd1dc33a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHO CP-GU M
Version Model NumberORTHO CP-GU M 15x30
Catalog Number55BHW
Company DUNS374444883
Company NameAGFA
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com
Phone+1(877)777-2432
Emailsalesinfo@agfa.com

Device Dimensions

Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter
Width30 Centimeter
Length15 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
Handling Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105414904197561 [Primary]
GS105414904220856 [Unit of Use]
GS105414904220863 [Package]
Contains: 05414904197561
Package: [5 Units]
In Commercial Distribution

FDA Product Code

IWZFilm, radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-08
Device Publish Date2022-07-29

On-Brand Devices [ORTHO CP-GU M]

05414904220863ORTHO CP-GU M 15x30
05414904220580ORTHO CP-GU M 28x35
05414904220627ORTHO CP-GU M 20x25
05414904220634ORTHO CP-GU M 25x30
05414904220719ORTHO CP-GU M 18x43
05414904220764ORTHO CP-GU M 35x43
05414904220825ORTHO CP-GU M 24x30
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