FDA UDI
In Commercial Distribution
🇺🇸 United States
1D SCANNER
DI: 05060608880096
·
Model: 1233500Z
·
SUN NUCLEAR CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 1D SCANNER
- Primary DI
- 05060608880096
- Version / Model
- 1233500Z
- Catalog Number
- 1233000-0Z
- Company Name
- SUN NUCLEAR CORP.
- Labeler DUNS
- 122240021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-06
- Public Version
- 1
- Public Version Date
- 2019-03-14
- Public Version Status
- New
- Public Device Record Key
- d493ddb3-9aa5-4391-9117-f387458996ca
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 40631 | Multi-modality therapeutic radiation phantom, test object | A device consisting of a variety of multi-modality radiation therapy phantom designs. It can consist of an object of uniform material density or a two or three-dimensional (3-D) model containing patterns of objects, materials, or openings. It is available in both fixed and variable configurations including holders for ionization chambers, dosimeters or other radiation measurement instruments. It is a quality assurance (QA) device used in the calibration of photon and electron beam emitting radiation therapy systems and the measurement of performance attributes, e.g., beam flatness, symmetry, dose depth or geometric accuracy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060608880096 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -22 – 122 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 64 – 86 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity