OPTION, NL4X00 WS-240V

GUDID 10815411020816

NEUROLOGICA CORP.

CT system workstation
Primary Device ID10815411020816
NIH Device Record Key6c42c38c-7893-415e-a0e9-6a87d4134815
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPTION, NL4X00 WS-240V
Version Model Number0-00132-003
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
GS110815411020816 [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 Date2023-08-23
Device Publish Date2023-08-15

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