FDA UDI
In Commercial Distribution
🇺🇸 United States
QED Detector, Electron (-) 1.5m
DI: 05060608880409
·
Model: 11120006Z
·
SUN NUCLEAR CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- QED Detector, Electron (-) 1.5m
- Primary DI
- 05060608880409
- Version / Model
- 11120006Z
- Catalog Number
- 11120006Z
- Company Name
- SUN NUCLEAR CORP.
- Labeler DUNS
- 122240021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-21
- Public Version
- 1
- Public Version Date
- 2019-05-29
- Public Version Status
- New
- Public Device Record Key
- 23a16c64-adf6-4e83-9d5b-5eeb13e43ae9
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 |
|---|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38336 | Solid-state-semiconductor radiation measuring probe | A device covering a variety of radiation detector probe designs incorporating a solid-state semiconductor serving as an ionization chamber. It is used as a component of a survey meter or analytical instrument used for radiation detection and measurement. It is typically used to detect low amounts of radioactivity and its energy discrimination properties allow it to be incorporated in radiation detection, measurement instruments and radiation spectroscopy systems. The composition and impurities in the semiconductor material used determine its energy discrimination capabilities and the kind of radiation (x-ray, gamma ray, high-energy beta particles or neutrons) that can be detected. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060608880409 | GS1 | ||||
| Previous | B01611120006Z0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K011466 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- When shipping a detector, always pack in a shipping container designed for fragile objects.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in an indoor, protected environment where the detector will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
- Type
- Special Storage Condition, Specify
- Special Conditions
- After cleaning, allow the detector, cable and connector to dry thoroughly, and then place in the storage case along with any accessories.
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 50 Degrees Celsius