FDA UDI
In Commercial Distribution
🇺🇸 United States
Rolence
DI: 04713909450628
·
Model: XR-01
·
ROLENCE ENTERPRISE INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Rolence
- Primary DI
- 04713909450628
- Version / Model
- XR-01
- Company Name
- ROLENCE ENTERPRISE INC.
- Labeler DUNS
- 656096658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-26
- Public Version
- 1
- Public Version Date
- 2021-05-04
- Public Version Status
- New
- Public Device Record Key
- 26525f76-c147-46ee-a2c1-1489921f6e61
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 |
| MUH | System, X-Ray, Extraoral Source, Digital | Dental | 872.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44606 | Hand-held intraoral dental x-ray system, digital | A 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. It is designed to be easily carried from location to location by a single operator. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. 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 | 04713909450628 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172928 | 000 |