MyoSPECT 5875815-10

GUDID 00195278421586

MyoSPECT GANTRY

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system
Primary Device ID00195278421586
NIH Device Record Key3ca6fed7-5066-486d-89d0-95f845f3fb3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyoSPECT
Version Model NumberH3912AA
Catalog Number5875815-10
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
GS100195278421586 [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 Date2021-10-15
Device Publish Date2021-10-07

On-Brand Devices [MyoSPECT]

00195278421586MyoSPECT GANTRY
00195278488619MyoSPECT MDR GANTRY

Trademark Results [MyoSPECT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MYOSPECT
MYOSPECT
88673302 not registered Live/Pending
GE PRECISION HEALTHCARE LLC
2019-10-30
MYOSPECT
MYOSPECT
78271568 not registered Dead/Abandoned
Segami Corporation
2003-07-08

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