MAMORAY HD EDBR1

GUDID 05414904008881

MAMORAY CASSETTE / HD

AGFA

X-ray film cassette, manual
Primary Device ID05414904008881
NIH Device Record Key4ebf940b-35d7-4f11-9789-4019f58590ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAMORAY HD
Version Model NumberMAMORAY HD 18X24
Catalog NumberEDBR1
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 Kittrue
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

Length18 Centimeter
Length18 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105414904008881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZHSystem, 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 [MAMORAY HD]

05414904009802MAMORAY CASSETTE / HD
05414904009345MAMORAY CASSETTE / HD
05414904008898MAMORAY CASSETTE / HD
05414904008881MAMORAY CASSETTE / HD

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