AccessGUDID - DEVICE: HoloXR Health Connect (G721HXR0)

GUDID

Device Identifier (DI) Information

Brand Name: HoloXR Health Connect
Version or Model: 1.0.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HXR
Company Name: Holoray Inc.

Primary DI Number: G721HXR0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 240687301 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65269	Clinical training/education software	A software program designed to train/educate a healthcare professional with respect to one or more clinical disease/disorder/condition. In addition to being an information platform it typically includes interactive features whereby, e.g., hypothetical patient data can be used to generate probabilities of presentation, diagnosis, and prognosis. It is not intended for real-case diagnostic or therapeutic purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMD	System, Digital Image Communications, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d2023b1-7275-4998-8098-c64c72882f17
Public Version Date: March 06, 2025
Public Version Number: 1
DI Record Publish Date: February 26, 2025