Cydar EV

GUDID 05060508110002

The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The software detects vertebral anatomical information present in

CYDAR LIMITED

Angiographic x-ray system application software
Primary Device ID05060508110002
NIH Device Record Keye4949acc-e803-4486-95c1-56173fa4243e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCydar EV
Version Model NumberEV-2
Company DUNS218286403
Company NameCYDAR 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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+16465200686
Emailsupport@cydarmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060508110002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

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 Date2017-04-21

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