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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | Radiology | 892.2020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G721HXR0 | HIBCC |