FDA UDI
In Commercial Distribution
🇺🇸 United States
Neck Phantom
DI: 00718175003657
·
Model: 043-365
·
BIODEX MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Neck Phantom
- Primary DI
- 00718175003657
- Version / Model
- 043-365
- Catalog Number
- 043-365
- Company Name
- BIODEX MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 043833813
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-15
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- c906086e-96a1-48b7-90e5-713cca3a691a
Device Description
Neck Phantom, Thyroid Uptake
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| IYP | Phantom, Anthropomorphic, Nuclear | Radiology | 892.1370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33115 | Nuclear medicine phantom, anthropomorphic | A device that consists of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to mimic the functional, physical, or a combination of these characteristics of normal or diseased human organs. It is used in diagnostic nuclear medicine and incorporates radioactive sealed sources or refillable cavities to which radioactivity can be added in order to simulate anticipated in vivo distributions of radiopharmaceuticals used in nuclear medicine imaging procedures. It is a quality assurance (QA) device permitting both subjective and quantitative evaluation of the overall function of photon detector systems, e.g., gamma camera, SPECT or PET. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00718175003657 | GS1 |