FDA UDI
In Commercial Distribution
🇺🇸 United States
NOMAD MD™ handheld X-ray system
DI: EKAV085004710
·
Model: 0.850.0471
·
ARIBEX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NOMAD MD™ handheld X-ray system
- Primary DI
- EKAV085004710
- Version / Model
- 0.850.0471
- Catalog Number
- FP 0202
- Company Name
- ARIBEX, INC.
- Labeler DUNS
- 169065526
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e6b23875-16e8-4c15-9e81-41115ab621c0
Device Description
Handheld x-ray
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
- Yes
- 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 |
|---|---|---|---|---|
| IZL | System, x-ray, mobile | Radiology | 892.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37607 | Diagnostic x-ray system generator, hand-held | An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a hand-held x-ray system, e.g., a system that is held during operation. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). It includes transformer and inverter generator designs. A hand-held x-ray system generators typically comprises a control assembly (console) and high voltage transformer assembly, but can also be a mono-tank generator design. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EKAV085004710 | HIBCC |
Customer Contacts
- Phone
- +18663405522
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140723 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 40 Degrees Celsius