SpotLight Duo

GUDID 07290016484021

SpotLight Duo is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system.

ARINETA LTD

Full-body CT system
Primary Device ID07290016484021
NIH Device Record Keyce2763a2-7812-4c1a-bb74-8bf6ca228bcd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpotLight Duo
Version Model NumberSpotLight
Company DUNS514896484
Company NameARINETA LTD
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 Numbertrue
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+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com
Phone+97246374040
Emailtanya.shalem@arineta.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016484021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-15
Device Publish Date2023-09-07

Devices Manufactured by ARINETA LTD

07290016484014 - SpotLight 2023-09-15 SpotLight is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system.
07290016484021 - SpotLight Duo2023-09-15SpotLight Duo is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system.
07290016484021 - SpotLight Duo2023-09-15 SpotLight Duo is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system.
07290016484007 - CardioGraphe2019-02-01 The CardioGraphe is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system.

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