DIRECTVIEW CR Mammography Cassette with HR Screen 1717446

GUDID 60889971717443

10SC 18X24CM ESCN HR PHOSPHOR SCR

CARESTREAM HEALTH, INC.

Digital imaging cassette/storage phosphor screen, mammographic
Primary Device ID60889971717443
NIH Device Record Key17fade55-3f0d-4b05-92ce-802ac4349256
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIRECTVIEW CR Mammography Cassette with HR Screen
Version Model NumberDIRECTVIEW CR Mammography Cassette with HR Screen
Catalog Number1717446
Company DUNS793169512
Company NameCARESTREAM HEALTH, INC.
Device Count10
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
GS100889971717441 [Unit of Use]
GS160889971717443 [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 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 HR Screen]

60889978364763DIRECTVIEW CR Mammo Cassett HR Scrn18x24
6088997171744310SC 18X24CM ESCN HR PHOSPHOR SCR
60889971650511DIRECTVIEW CR Cassett with HR Scrn 24x30

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