SoftROE

GUDID 00859474006557

SCC SOFT COMPUTER

Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software
Primary Device ID00859474006557
NIH Device Record Key2ddc4cab-80c8-4524-9a74-87fc667fca96
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoftROE
Version Model Number4.0.8.4
Company DUNS131311409
Company NameSCC SOFT COMPUTER
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100859474006557 [Primary]
GS100859474006557 [Primary]
GS100859474006557 [Primary]
GS100859474006557 [Primary]
GS100859474006557 [Primary]
GS100859474006557 [Primary]
GS100859474006557 [Primary]
GS100859474006557 [Primary]

FDA Product Code

JQPCalculator/Data Processing Module, For Clinical Use
JQPCalculator/Data Processing Module, For Clinical Use
JQPCalculator/Data Processing Module, For Clinical Use
JQPCalculator/Data Processing Module, For Clinical Use
JQPCalculator/Data Processing Module, For Clinical Use
JQPCalculator/Data Processing Module, For Clinical Use
JQPCalculator/Data Processing Module, For Clinical Use
JQPCalculator/Data Processing Module, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-31

On-Brand Devices [SoftROE]

008594740066184.5.5.51
008594740065714.5.7.3
008594740065574.0.8.4

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