Simplicit90Y

GUDID B334SY2P00

MIRADA MEDICAL LIMITED

Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation
Primary Device IDB334SY2P00
NIH Device Record Keycf0c9a9a-3c59-4953-b08d-792e86e9798b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimplicit90Y
Version Model Number2.0
Company DUNS211100325
Company NameMIRADA MEDICAL LIMITED
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 Datetrue
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
HIBCCB334SY2P00 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-15

On-Brand Devices [Simplicit90Y]

B334SY2P002.0
B334SY2P202.2
B334SY2P402.4
B334SY2P602.6
B334SY2P102.10
B334SY2P1202.12

Trademark Results [Simplicit90Y]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIMPLICIT90Y
SIMPLICIT90Y
88232299 not registered Live/Pending
Biocompatibles UK Limited
2018-12-17

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