CP-BU M XDAOG

GUDID 05414904237786

AGFA

Medical x-ray film, screen
Primary Device ID05414904237786
NIH Device Record Key10ee835a-c5a9-4e4e-8210-cb26ff045610
Commercial Distribution StatusIn Commercial Distribution
Brand NameCP-BU M
Version Model NumberCP-BU M 18x24
Catalog NumberXDAOG
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

Device Dimensions

Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter
Length18 Centimeter
Width24 Centimeter

Operating and Storage Conditions

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
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.

Device Identifiers

Device Issuing AgencyDevice ID
GS105414904237786 [Package]
Contains: 05414904237793
Package: [5 Units]
In Commercial Distribution
GS105414904237793 [Primary]
GS105414904237809 [Unit of Use]

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 Date2022-11-02
Device Publish Date2022-10-25

On-Brand Devices [CP-BU M]

05414904238028CP-BU M 18x43
05414904237991CP-BU M 28x35
05414904237908CP-BU M 15x30
05414904237816CP-BU M 24x30
05414904237786CP-BU M 18x24
05414904237755CP-BU M 20x25
05414904237724CP-BU M 25x30
05414904237496CP-BU M 35x43

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.