FDA UDI
In Commercial Distribution
🇺🇸 United States
Bi Image X-Evolution Wall
DI: 10850786008014
·
Model: EL-X20070
·
DPM USA CORP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bi Image X-Evolution Wall
- Primary DI
- 10850786008014
- Version / Model
- EL-X20070
- Catalog Number
- PC17B
- Company Name
- DPM USA CORP
- Labeler DUNS
- 007087206
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-08
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 21aa1e36-5c1e-408e-af60-1c29f0317206
Device Description
An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.
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
- Yes
- 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 |
|---|---|---|---|---|
| 45855 | Stationary extraoral dental x-ray system, digital | A diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed outside the mouth, the purpose being to visualize the entire mouth area showing teeth on both the upper and lower jaws. The data is either from analogue imaging and digitized afterwards or by digital imaging. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850786008014 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160458 | 000 |