CARESTREAM CR Mammography Cassette with SNP-M1 Scr 1941509

GUDID 60889971941503

18X24 CR MAMMO CASS W/SNP-M1 SCREEN

CARESTREAM HEALTH, INC.

Digital imaging cassette/storage phosphor screen, mammographic Digital imaging cassette/storage phosphor screen, mammographic
Primary Device ID60889971941503
NIH Device Record Key7c8df39e-c984-4b78-a10e-cbba9621bca0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARESTREAM CR Mammography Cassette with SNP-M1 Scr
Version Model NumberCARESTREAM CR Mammography Cassette with SNP-M1 Scr
Catalog Number1941509
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 Perscriptionfalse
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
GS140889971941509 [Primary]
GS160889971941503 [Package]
Contains: 40889971941509
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 [CARESTREAM CR Mammography Cassette with SNP-M1 Scr]

6088997821520124X30 CR MAMMO CASS W/SNP-M1 SCREEN
60889971978608CARESTREAM CR Cassette 35x43 / 14x17
6088997194150318X24 CR MAMMO CASS W/SNP-M1 SCREEN

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