DLIR

GUDID 00840682146586

GE HEALTHCARE JAPAN CORPORATION

CT system application software
Primary Device ID00840682146586
NIH Device Record Key307df56a-9c66-41a4-b9aa-ed6e47fd4657
Commercial Distribution StatusIn Commercial Distribution
Brand NameDLIR
Version Model Number1.0
Company DUNS696021596
Company NameGE HEALTHCARE JAPAN 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 Batchtrue
Serial Numberfalse
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
GS100840682146586 [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 Date2020-03-02
Device Publish Date2020-02-21

On-Brand Devices [DLIR]

008406821465861.0
00195278303202DLIR Application Container for Smart Subscription
00195278620453SWMD DLIR Application for Smart Subscription

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