Mamoray HDR-C Plus EMG8K

GUDID 05414904225066

AGFA

Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen Medical x-ray film, screen
Primary Device ID05414904225066
NIH Device Record Keyd1eb744c-eece-4df2-aaef-d38c402733b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMamoray HDR-C Plus
Version Model NumberMAMORAY HDR-C PLUS 18x24
Catalog NumberEMG8K
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

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
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.
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
GS105414904009901 [Primary]
GS105414904225059 [Unit of Use]
GS105414904225066 [Package]
Contains: 05414904009901
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 Date2022-11-24
Device Publish Date2022-11-16

Devices Manufactured by AGFA

05414904271124 - SE Suite2023-10-18 Software
05414904208168 - NX 3.02023-07-26
05414904233320 - NX 4.02023-07-26
05414904281321 - DR 4002023-03-31
05414904225066 - Mamoray HDR-C Plus2022-11-24
05414904225066 - Mamoray HDR-C Plus2022-11-24
05414904231678 - Dentus M2 Comfort2022-11-24
05414904231692 - Dentus M2 Comfort2022-11-24
05414904231531 - Dentus Ortholux Register2022-11-14
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.