FDA UDI In Commercial Distribution 🇺🇸 United States

EXCELSIUS GPS

DI: 00193982185220 · Model: 6143.2505 · GLOBUS MEDICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
EXCELSIUS GPS
Primary DI
00193982185220
Version / Model
6143.2505
Company Name
GLOBUS MEDICAL, INC.
Labeler DUNS
139105691
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-09-23
Public Version
2
Public Version Date
2023-06-19
Public Version Status
Update
Public Device Record Key
efaf30bb-6660-41c9-925d-9a248da0b917

Device Description

Patient Stabilization Stand

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HAW Neurological stereotaxic Instrument
OLO Orthopedic stereotaxic instrument

GMDN Terms

Code Name
38678 Robotic surgical arm system

Identifiers

Type ID
Primary 00193982185220

Premarket Submissions

Submission Number Supplement Number
K200047 000