830 to 870 DR Upgrade

GUDID 00840682146401

G E MEDICAL SYSTEMS ISRAEL LTD.

Full-body CT system
Primary Device ID00840682146401
NIH Device Record Key8613bdc7-a368-4e3d-b0fc-08abf570577b
Commercial Distribution StatusIn Commercial Distribution
Brand Name830 to 870 DR Upgrade
Version Model NumberH3906ER
Company DUNS532102365
Company NameG E MEDICAL SYSTEMS ISRAEL LTD.
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
GS100840682146401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPSSystem, tomography, computed, emission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-27
Device Publish Date2019-09-19

On-Brand Devices [830 to 870 DR Upgrade]

00840682146401H3906ER
00840682145459H3906DT

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