FDA UDI
Not in Commercial Distribution
🇺🇸 United States
KaVo NOMAD Pro 2
DI: EKAV101329300
·
Model: 1.013.2930
·
Dental Imaging Technologies Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KaVo NOMAD Pro 2
- Primary DI
- EKAV101329300
- Version / Model
- 1.013.2930
- Company Name
- Dental Imaging Technologies Corporation
- Labeler DUNS
- 800111106
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-21
- Public Version
- 6
- Public Version Date
- 2022-08-30
- Public Version Status
- Update
- Public Device Record Key
- 721525a3-ea50-4f52-b911-bf4f6a75b8a9
- Distribution End Date
- 2022-03-11
Device Description
KaVo NOMAD Pro 2, GBL
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
- 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 |
|---|---|---|---|---|
| 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 | EKAV101329300 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173319 | 000 |