FDA UDI
In Commercial Distribution
🇺🇸 United States
OMNERA 500A
DI: 07350008750098
·
Model: Precision i5
·
Arcoma AB
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OMNERA 500A
- Primary DI
- 07350008750098
- Version / Model
- Precision i5
- Company Name
- Arcoma AB
- Labeler DUNS
- 356774109
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-30
- Public Version
- 1
- Public Version Date
- 2022-04-07
- Public Version Status
- New
- Public Device Record Key
- 2f0c33db-867d-415d-982f-03874cc50e4d
Device Description
Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.
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
- 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 |
|---|---|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | Immunology | 866.5660 | 2 |
| KPR | System, X-Ray, Stationary | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37645 | Stationary basic diagnostic x-ray system, digital | An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350008750098 | GS1 |
Customer Contacts
- Phone
- +46470706900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140683 | 000 |