CRYSTAL FILM CF-B 5YH1A

GUDID 05414904226766

AGFA

Medical printer film
Primary Device ID05414904226766
NIH Device Record Key5305f820-19a7-44a6-895e-8557eea2ce4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRYSTAL FILM CF-B
Version Model NumberCRYSTAL FILM CF-B 25 x 30
Catalog Number5YH1A
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105414904161876 [Primary]
GS105414904226759 [Unit of Use]
GS105414904226766 [Package]
Contains: 05414904161876
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-B]

05414904226728CRYSTAL FILM CF-B 35 x 43
05414904226742CRYSTAL FILM CF-B 28 x 35
05414904226766CRYSTAL FILM CF-B 25 x 30
05414904226643CRYSTAL FILM CF-B 20 x 25

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