Ventri

GUDID 00840682121644

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system
Primary Device ID00840682121644
NIH Device Record Keyc8e05298-1677-414b-8153-2af05097405d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVentri
Version Model NumberH3000YT
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
GS100840682121644 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-22

Devices Manufactured by G E MEDICAL SYSTEMS ISRAEL LTD.

00195278870490 - StarGuide MDD to MDR Upgrade2024-05-24 StarGuide SW and Labels Upgrade
00195278755544 - StarGuide2024-04-26 StarGuide NM GANTRY MDR FINAL
00195278794772 - D630 to D670 DR Upgrade2024-03-26 D630 to D670 DR NM GANTRY UPGRADE KIT
00195278788252 - NM2023-11-23 830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
00195278788269 - NMCT2023-11-22 870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE
00195278488619 - MyoSPECT2023-09-22 MyoSPECT MDR GANTRY
00195278488626 - MyoSPECT ES2023-09-22 MyoSPECT ES MDR GANTRY
00195278722546 - MyoSEPCT ES to MyoSPECT Upgrade2023-09-22 MyoSPECT ES to MyoSPECT Upgrade kit

Trademark Results [Ventri]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VENTRI
VENTRI
78610635 3160750 Dead/Cancelled
General Electric Company
2005-04-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.