DIRECTVIEW CR Mammography Cassette with EHR-M Scre 1667575

GUDID 60889971667571

DIRECTVW CR Mammo Cass EHR-M2 Scrn 24x30

CARESTREAM HEALTH, INC.

Digital imaging cassette/storage phosphor screen, mammographic
Primary Device ID60889971667571
NIH Device Record Key202d7ee9-e095-46b3-82f5-d06a919d6bae
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIRECTVIEW CR Mammography Cassette with EHR-M Scre
Version Model NumberDIRECTVIEW CR Mammography Cassette with EHR-M Scre
Catalog Number1667575
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS140889971667577 [Primary]
GS160889971667571 [Package]
Contains: 40889971667577
Package: Case [4 Units]
In Commercial Distribution

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [DIRECTVIEW CR Mammography Cassette with EHR-M Scre]

6088997861161424X30CM DV REPLCMT PLATE/EHR-M2 SCR
6088997846332918X24CM DV REPLCMT PLATE/EHR-M2 SCR
6088997835915824X30CM DVIEW CR MAMMO SCR EHR-M2
6088997834613424X30CM DVIEW CR MAMMO SCR EHR-M
60889978792122DIRECTVW CR Mammo Cass EHR-M Scrn 24x30
6088997818834518X24CM DVIEW CR MAMMO SCR EHR-M
60889971667571DIRECTVW CR Mammo Cass EHR-M2 Scrn 24x30
60889971508270DIRECTVW CR Mammo Cass EHR-M Scrn 18x24
6088997134286718X24CM DVIEW CR MAMMO SCR EHR-M2
60889971290380DIRECTVW CR Mammo Cass EHR-M2 Scrn 18x24

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