NM

GUDID 00840682140829

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system
Primary Device ID00840682140829
NIH Device Record Keyb39a2038-8933-4e3f-b72e-363499083327
Commercial Distribution StatusIn Commercial Distribution
Brand NameNM
Version Model Number830
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
GS100840682140829 [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 Number2
Public Version Date2018-07-06
Device Publish Date2018-05-15

On-Brand Devices [NM]

00840682140829830
00195278788252830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE

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