FDA UDI
In Commercial Distribution
🇺🇸 United States
XZeal Z70 Mobile
DI: 00868923000237
·
Model: On wheels
·
XZEAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XZeal Z70 Mobile
- Primary DI
- 00868923000237
- Version / Model
- On wheels
- Catalog Number
- XZ021
- Company Name
- XZEAL TECHNOLOGIES, INC.
- Labeler DUNS
- 041863955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0378a9f1-d98a-440c-b68a-8a20ce17a9f4
Device Description
The XZeal Z70 Mobile is an X-Ray source to produce intraoral images for the diagnosis of teeath and adjacent structures.
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 | 00868923000237 | GS1 |
Customer Contacts
- Phone
- 407 483-8859
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122582 | 000 |