FDA UDI
In Commercial Distribution
🇺🇸 United States
IC PROFILER
DI: 05060608880751
·
Model: 1122800Z
·
SUN NUCLEAR CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IC PROFILER
- Primary DI
- 05060608880751
- Version / Model
- 1122800Z
- Catalog Number
- 1122000-0Z
- Company Name
- SUN NUCLEAR CORP.
- Labeler DUNS
- 122240021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-23
- Public Version
- 1
- Public Version Date
- 2020-07-31
- Public Version Status
- New
- Public Device Record Key
- 8889735c-0182-47ab-b391-412b01b2c6a4
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| LHO | Instrument, Quality-Assurance, Radiologic | Radiology | 892.1940 | 1 |
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 | 05060608880751 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Never store device 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
- CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
- Type
- Special Storage Condition, Specify
- Special Conditions
- When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
- Type
- Special Storage Condition, Specify
- Special Conditions
- If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
- Type
- Special Storage Condition, Specify
- Special Conditions
- Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage