Sim&Size

GUDID 03665786000056

SIM&CURE

Radiology DICOM image processing application software
Primary Device ID03665786000056
NIH Device Record Key18307452-82e1-4523-86bd-9930ab79e766
Commercial Distribution StatusIn Commercial Distribution
Brand NameSim&Size
Version Model NumberV1.0.7
Company DUNS266338887
Company NameSIM&CURE
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103665786000056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZOSoftware For Visualization Of Vascular Anatomy And Intravascular Devices

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-14
Device Publish Date2021-06-06

On-Brand Devices [Sim&Size]

03665786000025Version 1.0.5
03665786000056V1.0.7
03665786000049V1.0.6
03665786000063V1.1
03665786000032V1.2

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