FDA UDI
In Commercial Distribution
🇺🇸 United States
Capintec NEMA IEC NM Body Phantom
DI: 05060608882038
·
Model: NMP0273
·
SUN NUCLEAR CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Capintec NEMA IEC NM Body Phantom
- Primary DI
- 05060608882038
- Version / Model
- NMP0273
- Company Name
- SUN NUCLEAR CORP.
- Labeler DUNS
- 122240021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-07
- Public Version
- 1
- Public Version Date
- 2025-11-17
- Public Version Status
- New
- Public Device Record Key
- 727dff32-80ff-42b3-8bda-b37f92cbf7ad
Device Description
The NEMA IEC Nuclear Medicine Body Phantom is intended to establish, validate and provide for routine and periodic verification of nuclear medicine imaging device consistent with internationally recognized standards.
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 |
|---|---|---|---|---|
| JAR | Phantom, Test-Pattern, Radionuclide | Radiology | 892.1420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40616 | Multi-modality diagnostic imaging phantom, test object | A device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations and is a quality assurance device used in both subjective and quantitative evaluations of various calibration and performance characteristics of diagnostic imaging systems. A multi-modality phantom is specifically intended for use with more than one diagnostic imaging modality, e.g., magnetic resonance imaging (MRI), ultrasound, x-ray and nuclear medicine (NM) systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060608882038 | GS1 |
Customer Contacts
- Phone
- +1 321-259-6862
- [email protected]