FDA UDI
In Commercial Distribution
🇺🇸 United States
Sun Nuclear CT ACR 464 Phantom
DI: B1364640
·
Model: 464
·
SUN NUCLEAR CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sun Nuclear CT ACR 464 Phantom
- Primary DI
- B1364640
- Version / Model
- 464
- Company Name
- SUN NUCLEAR CORP.
- Labeler DUNS
- 122240021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-25
- Public Version
- 2
- Public Version Date
- 2023-01-09
- Public Version Status
- Update
- Public Device Record Key
- 947a0ef5-44e1-4f31-9565-92acc9f5bf05
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 |
|---|---|---|---|---|
| 40603 | CT phantom, test object | A device that consist of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions that comes in both fixed and variable configurations. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of diagnostic x-ray computed tomography (CT) imaging systems and associated image acquisition, display, and analysis computer programs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B1364640 | HIBCC |