FDA UDI
In Commercial Distribution
🇺🇸 United States
ASM, CS-7 QC PHANTOM
DI: 04068151007930
·
Model: 10751221
·
SIEMENS MEDICAL SOLUTIONS USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ASM, CS-7 QC PHANTOM
- Primary DI
- 04068151007930
- Version / Model
- 10751221
- Company Name
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Labeler DUNS
- 868230876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-29
- Public Version
- 1
- Public Version Date
- 2023-12-07
- Public Version Status
- New
- Public Device Record Key
- 4f4a1ae6-6f33-4ab3-a176-2121494a5938
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
- Yes
- 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 |
|---|---|---|---|---|
| IXD | Source, calibration, sealed, nuclear | Radiology | 892.1400 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40630 | Nuclear medicine phantom, test object | A device that includes a wide variety of two or three-dimensional (3-D) phantoms used in both calibration protocols and in subjective and quantitative evaluations of the performance of diagnostic nuclear medicine (NM) detector systems, e.g., gamma cameras, single photon emission computed tomography (SPECT), positron emission tomography (PET) or associated image display system and software programs. It consists of either fixed or variable configurations or patterns of absorbing or attenuating materials and radioactive source holders. The design can incorporate radioactive sealed sources or refillable radioactive source wells to which radioactivity can be added. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04068151007930 | GS1 |
Customer Contacts
- Phone
- +1(800)888-7436
- [email protected]