MAMORAY HD S EDB1L

GUDID 05414904008966

MAMORAY CASSETTE / HD S

AGFA

X-ray film cassette, manual
Primary Device ID05414904008966
NIH Device Record Key7c2405b2-5375-4c8e-a57f-abb9048d6bf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAMORAY HD S
Version Model NumberMAMORAY HD S 18X24
Catalog NumberEDB1L
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
GS105414904008966 [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 S]

05414904009796MAMORAY CASSETTE / HD S
05414904008966MAMORAY CASSETTE / HD S
05414904008959MAMORAY CASSETTE / HD S
05414904008942MAMORAY CASSETTE / HD S

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