EXCELSIUS3D

GUDID 00193982184506

Excelsius3D

GLOBUS MEDICAL, INC.

Portable general-purpose fluoroscopic x-ray system, digital
Primary Device ID00193982184506
NIH Device Record Key54045c5f-954e-4b4c-9817-bcbf2cc8767e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXCELSIUS3D
Version Model Number6161.1000
Company DUNS139105691
Company NameGLOBUS MEDICAL, INC.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100193982184506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OXOImage-intensified fluoroscopic x-ray system, mobile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-04
Device Publish Date2024-06-26

On-Brand Devices [EXCELSIUS3D]

00193982184537Mobile Monitor
00193982184506Excelsius3D

Trademark Results [EXCELSIUS3D]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXCELSIUS3D
EXCELSIUS3D
90884243 not registered Live/Pending
Globus Medical, Inc.
2021-08-16

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