FDA UDI
In Commercial Distribution
🇺🇸 United States
Raypilot Power Box
DI: 07350007956033
·
Model: 1
·
Micropos Medical AB (Publ)
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Raypilot Power Box
- Primary DI
- 07350007956033
- Version / Model
- 1
- Catalog Number
- 6003
- Company Name
- Micropos Medical AB (Publ)
- Labeler DUNS
- 350533316
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-04
- Public Version
- 1
- Public Version Date
- 2023-04-12
- Public Version Status
- New
- Public Device Record Key
- aaed67ca-f38a-4e56-a512-310de0396b24
- Distribution End Date
- 2053-02-28
Device Description
Raypilot Power Box is connected between electrical supply and Raypilot Receiver by Raypilot Transmitter Cable. It is also connected to the dedicated computer by an ethernet cable.
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46467 | Radiation therapy invasive marker lesion localization system | An assembly of noninvasive devices intended to monitor the position of a patient's tumour/lesion relative to the isocenter of a radiation therapy system, to assist with their alignment during treatment planning or a therapeutic procedure. It localizes the position of invasive markers [e.g., electromagnetic (EM) signal transmitters, radiopaque markers] (not included) which have been introduced/implanted in or near the target site prior to treatment. It typically includes an EM receiver and dedicated software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350007956033 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203722 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius