Horizontal

GUDID 00840682139397

GE MEDICAL SYSTEMS

Stationary mammographic x-ray system, digital
Primary Device ID00840682139397
NIH Device Record Key30c365d2-c487-4587-b934-358cf96f257f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHorizontal
Version Model NumberJMM1
Company DUNS266062561
Company NameGE MEDICAL SYSTEMS
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

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682139397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUEFull field digital, system, x-ray, mammographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-05
Device Publish Date2018-05-25

Devices Manufactured by GE MEDICAL SYSTEMS

00195278866899 - not applicable2024-06-17 Software Pristina 8.4 - ISO file
00195278719812 - not applicable2024-04-19 Software Pristina ME 9.2 - ISO file
00195278534064 - Spine Auto Views2024-03-19 Spine Auto Views Medical Device
00195278795724 - not applicable2024-01-30 Software Pristina 8.3 - ISO file
00195278719263 - Allia2023-12-18 Allia IGS5 UDI
00195278719577 - Allia2023-12-18 Allia IGS3 UDI
00195278719720 - Allia2023-12-18 Allia IGS 7 UDI
00195278719744 - Allia2023-12-18 Allia IGS 7 OR UDI

Trademark Results [Horizontal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HORIZONTAL
HORIZONTAL
88420497 not registered Live/Pending
Horizontal Integration, Inc.
2019-05-08
HORIZONTAL
HORIZONTAL
87369522 not registered Dead/Abandoned
Osborne Seleccion, S.A.
2017-03-13
HORIZONTAL
HORIZONTAL
87345164 not registered Dead/Abandoned
Golik, Nina
2017-02-22
HORIZONTAL
HORIZONTAL
87345164 not registered Dead/Abandoned
Golik, Billy
2017-02-22
HORIZONTAL
HORIZONTAL
87345164 not registered Dead/Abandoned
Golik, William
2017-02-22
HORIZONTAL
HORIZONTAL
87345164 not registered Dead/Abandoned
Golik, Beatriz
2017-02-22
HORIZONTAL
HORIZONTAL
79007437 3051164 Dead/Cancelled
Dr. Achim Hansjürgens
2004-06-23
HORIZONTAL
HORIZONTAL
78971478 3413520 Dead/Cancelled
RIZZIL, LLC
2006-09-11
HORIZONTAL
HORIZONTAL
78096421 not registered Dead/Abandoned
Hansjurgens, Kai
2001-12-04
HORIZONTAL
HORIZONTAL
78096421 not registered Dead/Abandoned
Hansjuergens, Achim
2001-12-04
HORIZONTAL
HORIZONTAL
77855235 3806313 Dead/Cancelled
Horizontal LLC
2009-10-22
HORIZONTAL
HORIZONTAL
77675571 3685578 Dead/Cancelled
Horizontal LLC
2009-02-22

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