FDA UDI
In Commercial Distribution
🇺🇸 United States
Lodox
DI: 06009880828128
·
Model: eXero-dr
·
LODOX SYSTEMS (PTY) LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lodox
- Primary DI
- 06009880828128
- Version / Model
- eXero-dr
- Catalog Number
- CL-08-0013-H11
- Company Name
- LODOX SYSTEMS (PTY) LTD
- Labeler DUNS
- 635684694
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-10
- Public Version
- 2
- Public Version Date
- 2021-08-13
- Public Version Status
- Update
- Public Device Record Key
- 6cca13ca-c39b-4acf-a5fe-1540a924360c
Device Description
The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiography cases as well as in forensic pathology cases.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37645 | Stationary basic diagnostic x-ray system, digital | An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06009880828128 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013999 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 40 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 45 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal