CereTom Elite

GUDID 10815411020687

NEUROLOGICA CORP.

Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system
Primary Device ID10815411020687
NIH Device Record Keyb11ece84-d3ae-4b27-a611-aeb7be86c34b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCereTom Elite
Version Model Number0-NL3000-004
Company DUNS145008178
Company NameNEUROLOGICA CORP.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110815411020687 [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 Date2022-02-23
Device Publish Date2022-02-15

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10815411020687 - CereTom Elite2022-02-23
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