FDA UDI
In Commercial Distribution
🇺🇸 United States
x-mind dc
DI: D804592151030
·
Model: DC X-MIND 115V,SHORT CONE,MOBILE
·
DE GÖTZEN SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- x-mind dc
- Primary DI
- D804592151030
- Version / Model
- DC X-MIND 115V,SHORT CONE,MOBILE
- Catalog Number
- 5.92.15103
- Company Name
- DE GÖTZEN SRL
- Labeler DUNS
- 433051802
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-11
- Public Version
- 1
- Public Version Date
- 2024-01-19
- Public Version Status
- New
- Public Device Record Key
- b4cc62bb-e66c-4b45-9877-07da6a4cb074
Device Description
x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device.
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 |
|---|---|---|---|---|
| 33109 | Mobile intraoral dental x-ray system, digital | A mobile (on wheels) diagnostic dental x-ray system designed 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 in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D804592151030 | HIBCC |
Customer Contacts
- Phone
- +390331376760
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231055 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 25 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 85 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 25 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 85 – 106 KiloPascal