FDA UDI
In Commercial Distribution
🇺🇸 United States
RadQual
DI: 00850020470037
·
Model: BM05
·
RADQUAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RadQual
- Primary DI
- 00850020470037
- Version / Model
- BM05
- Company Name
- RADQUAL, LLC
- Labeler DUNS
- 008841076
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-07
- Public Version
- 1
- Public Version Date
- 2020-08-17
- Public Version Status
- New
- Public Device Record Key
- ca95188c-e2f5-46b3-8087-183232f44a3b
Device Description
Square Digirad Phantom Co 57
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
- No
- 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 |
|---|---|---|---|---|
| IYQ | Phantom, Flood Source, Nuclear | Radiology | 892.1380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40606 | Nuclear medicine phantom, flood source | A device which is either a radioactive sealed source or a water-filled radiolucent disc or other shape to which radioactivity can be added. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of photon detector systems used in nuclear medicine applications 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 | 00850020470037 | GS1 |