FDA UDI
In Commercial Distribution
🇺🇸 United States
Raypilot Hypocath
DI: 07350007951045
·
Model: 1
·
Micropos Medical AB (Publ)
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Raypilot Hypocath
- Primary DI
- 07350007951045
- Version / Model
- 1
- Catalog Number
- 1004
- 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
- 21868044-576b-4eca-af24-1e91ec1d71c2
- Distribution End Date
- 2053-02-28
Device Description
Raypilot Hypocath is inteded for real time localization of a target during radiation therapy for men with prostate cancer. It is a Foley catheter with a transmitter inserted in one of the lumens. The catheter ensures urine drainage through the duration of the radiation therapy.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 65705 | Radiation therapy lesion localization urethral catheter, procedural | A flexible tube with an electrically-powered localization marker [e.g., electromagnetic (EM) transmitter] at its distal end intended to be introduced into the prostatic urethra, to create an identifying mark, for the alignment and monitoring of a patient's tumour/lesion position relative to the isocenter of a radiation therapy system during a therapeutic procedure. It may allow urinary drainage or incorporate a balloon for stabilization. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350007951045 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203722 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- 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