DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen 1044296

GUDID 60889971044297

CRMAMMO CASSETTE W/EHR M3 SCREEN 24X30

CARESTREAM HEALTH, INC.

Digital imaging cassette/storage phosphor screen, mammographic
Primary Device ID60889971044297
NIH Device Record Key4fa8b618-7c2d-4154-9502-a73a7e1c8c04
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIRECTVIEW CR Mammography Cassette with EHR-M3 Screen
Version Model NumberDIRECTVIEW CR Mammography Cassette with EHR-M3 Scr
Catalog Number1044296
Company DUNS793169512
Company NameCARESTREAM HEALTH, INC.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160889971044297 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-14
Device Publish Date2021-06-06

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