FDA UDI
In Commercial Distribution
🇺🇸 United States
3D Reservoir
DI: B01612300002Z0
·
Model: 12300002Z
·
SUN NUCLEAR CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3D Reservoir
- Primary DI
- B01612300002Z0
- Version / Model
- 12300002Z
- Catalog Number
- 12300002Z
- Company Name
- SUN NUCLEAR CORP.
- Labeler DUNS
- 122240021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 92e94436-9b94-49f6-a9de-e53371691a0e
Device Description
Accessory to the 1230 3D SCANNER.
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 | B01612300002Z0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101992 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Never store the 3D Reservoir where it can accidentally be irradiated.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Never expose the electronics portion of the 3D Reservoir to the beam, including where it could be exposed during rotation.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store equipment inside the 3D Reservoir.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store equipment on top of the 3D Reservoir.
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.