DLIR 5928863

GUDID 00195278620453

SWMD DLIR Application for Smart Subscription

GE HEALTHCARE JAPAN CORPORATION

CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software
Primary Device ID00195278620453
NIH Device Record Key24f27b81-dc16-445a-92c3-e395735414d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDLIR
Version Model Number1.2
Catalog Number5928863
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 Datefalse
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
GS100195278620453 [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 Date2023-07-10
Device Publish Date2023-06-30

On-Brand Devices [DLIR]

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

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