FDA UDI
In Commercial Distribution
🇺🇸 United States
NOMAD Pro 2™
DI: EKAV085000260
·
Model: 0.850.0026
·
ARIBEX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NOMAD Pro 2™
- Primary DI
- EKAV085000260
- Version / Model
- 0.850.0026
- Catalog Number
- FP 0190 HSC
- 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
- e38e8ac1-beb1-40a5-adaa-8abb20079294
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 |
|---|---|---|---|---|
| EHD | UNIT, X-RAY, EXTRAORAL WITH TIMER | Dental | 872.1800 | 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 | EKAV085000260 | HIBCC |
Customer Contacts
- Phone
- +18663405522
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081664 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 40 Degrees Celsius