CR HD5.0 AEC CASSETTE 5PCQV

GUDID 05414904044155

CR HD5.0 AEC CASSETTE 35X43CM

AGFA

Digital imaging cassette
Primary Device ID05414904044155
NIH Device Record Key2ce919a3-e45a-49e5-bb30-7fca6c7a54af
Commercial Distribution StatusIn Commercial Distribution
Brand NameCR HD5.0 AEC CASSETTE
Version Model NumberCR HD5.0 AEC CASSETTE 35X43
Catalog Number5PCQV
Company DUNS374444883
Company NameAGFA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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

Device Dimensions

Length35 Centimeter
Length35 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105414904044155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUEFull field digital,system,x-ray,mammographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-14
Device Publish Date2016-09-01

On-Brand Devices [CR HD5.0 AEC CASSETTE]

05414904044179CR HD5.0 AEC CASSETTE 18X24CM
05414904044162CR HD5.0 AEC CASSETTE 24X30CM
05414904044155CR HD5.0 AEC CASSETTE 35X43CM

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