FDA UDI
In Commercial Distribution
🇺🇸 United States
Planmeca Romexis
DI: 06430035420599
·
Model: 6
·
Planmeca Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Planmeca Romexis
- Primary DI
- 06430035420599
- Version / Model
- 6
- Catalog Number
- 10041546
- Company Name
- Planmeca Oy
- Labeler DUNS
- 368788568
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-14
- Public Version
- 1
- Public Version Date
- 2023-06-22
- Public Version Status
- New
- Public Device Record Key
- 82def1a7-f6d8-4657-b02d-1ce2d1395388
Device Description
Planmeca Romexis is a modular imaging software for dental and medical use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40878 | Panoramic/tomographic dental x-ray system application software | An application or operating data program designed for use in, or together with a panoramic/tomographic dental x-ray system configuration. A basic set of applications programs and routines are included with any computer-controlled diagnostic imaging system. Some applications software routines or groups of routines (packages) must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430035420599 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200572 | 000 |