Cardius 3

GUDID 00850816007089

DIGIRAD CORPORATION

SPECT system, annular detector array
Primary Device ID00850816007089
NIH Device Record Keyf1a0b4d3-4804-4aa7-b941-d6821d829c7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardius 3
Version Model NumberMobile XPOD
Company DUNS148548738
Company NameDIGIRAD CORPORATION
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

Phone8587261600
Emailcallcenter@digirad.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850816007089 [Primary]

FDA Product Code

KPSSystem, Tomography, Computed, Emission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-09

On-Brand Devices [Cardius 3]

00850816007089Mobile XPOD
00850816007072XPOD

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