FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PROFILER 2
DI: B01611740000Z0
·
Model: 11740000Z
·
SUN NUCLEAR CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PROFILER 2
- Primary DI
- B01611740000Z0
- Version / Model
- 11740000Z
- Catalog Number
- 11740000Z
- Company Name
- SUN NUCLEAR CORP.
- Labeler DUNS
- 122240021
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-14
- Public Version
- 5
- Public Version Date
- 2019-05-23
- Public Version Status
- Update
- Public Device Record Key
- 5c76b84e-9fb3-4ad0-a4af-0bb1490ecc1e
- Distribution End Date
- 2019-05-23
Device Description
Radiation therapy QA device.
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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| 38399 | Accelerator system quality assurance device | An instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B01611740000Z0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063021 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep the electronics out of the beam during concatenation, rotation, and offset.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid frequent use of thick buildup, which may cause scattered radiation that will damage the electronics.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Never leave the instrument on the couch during warm-up.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Never expose the electronics portion of the instrument to the direct beam.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the PROFILER 2 in an indoor, protected environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 50 Degrees Celsius