DIRECTVIEW CR Mammography Cassette with EHR-M3 Scr 1790310

GUDID 60889971790316

DIRECTVW CR Mammo Cass EHR-M3 Scrn 18X24

CARESTREAM HEALTH, INC.

Digital imaging cassette/storage phosphor screen, mammographic
Primary Device ID60889971790316
NIH Device Record Key7979ecca-38a6-4740-96cf-5a71fd3b70dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIRECTVIEW CR Mammography Cassette with EHR-M3 Scr
Version Model NumberDIRECTVIEW CR Mammography Cassette with EHR-M3 Scr
Catalog Number1790310
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
GS140889971790312 [Primary]
GS160889971790316 [Package]
Contains: 40889971790312
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-M3 Scr]

6088997886984824X30CM CR MAMMO SCR EHR-M3
6088997833619718X24CM CR MAMMO SCR EHR-M3
60889978156184DIRECTVW CR Mammo Cass EHR-M3 Scrn 24x30
60889971790316DIRECTVW CR Mammo Cass EHR-M3 Scrn 18X24

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