Revolution Apex B7919YO

GUDID 00195278788665

Revolution Apex Select with Plus Edition - Designated System Medical Device

Hangwei GE Medical Systems Co., Ltd.

Full-body CT system
Primary Device ID00195278788665
NIH Device Record Key87b44488-3474-4839-bdcb-b31d62c9a030
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevolution Apex
Version Model NumberSelect with Plus Edition
Catalog NumberB7919YO
Company DUNS654659689
Company NameHangwei GE Medical Systems Co., 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 Datefalse
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
GS100195278788665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, x-ray, tomography, computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-03
Device Publish Date2023-12-26

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Trademark Results [Revolution Apex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REVOLUTION APEX
REVOLUTION APEX
87586210 not registered Live/Pending
General Electric Company
2017-08-28

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