FDA UDI In Commercial Distribution 🇺🇸 United States

HoloXR Health Connect

DI: G721HXR0 · Model: 1.0.0 · Holoray Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HoloXR Health Connect
Primary DI
G721HXR0
Version / Model
1.0.0
Catalog Number
HXR
Company Name
Holoray Inc.
Labeler DUNS
240687301
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-02-26
Public Version
1
Public Version Date
2025-03-06
Public Version Status
New
Public Device Record Key
2d2023b1-7275-4998-8098-c64c72882f17

Device Description

The HoloXR Health Connect is an adjunctive tool to facilitate telecollaboration and consultation to gain the ability of leverage specialized clinicians for collaborative care from any location during surgical and outpatient procedures through real-time transmission of visual and auditory information.

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
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LMD System, Digital Image Communications, Radiological

GMDN Terms

Code Name
65269 Clinical training/education software

Identifiers

Type ID
Primary G721HXR0