CRYSTAL FILM CF-M 5YH5J

GUDID 05414904226681

AGFA

Medical printer film
Primary Device ID05414904226681
NIH Device Record Keyf3786aa4-a9e1-4de0-89ae-beaa39b0864f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRYSTAL FILM CF-M
Version Model NumberCRYSTAL FILM CF-M 25 x 30
Catalog Number5YH5J
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

Device Dimensions

Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 Centimeter
Width30 Centimeter
Length25 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).
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).
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).
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).
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).

Device Identifiers

Device Issuing AgencyDevice ID
GS105414904161845 [Primary]
GS105414904226674 [Unit of Use]
GS105414904226681 [Package]
Contains: 05414904161845
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 Date2022-11-08
Device Publish Date2022-10-31

On-Brand Devices [CRYSTAL FILM CF-M]

05414904226667CRYSTAL FILM CF-M 28 x 35
05414904226681CRYSTAL FILM CF-M 25 x 30
05414904226704CRYSTAL FILM CF-M 20 x 25

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