FDA UDI
In Commercial Distribution
🇺🇸 United States
ECTphan™
DI: 00812266030628
·
Model: SMR350
·
Providus Holdings, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ECTphan™
- Primary DI
- 00812266030628
- Version / Model
- SMR350
- Catalog Number
- SMR350
- Company Name
- Providus Holdings, Inc.
- Labeler DUNS
- 104162493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-11
- Public Version
- 1
- Public Version Date
- 2024-03-19
- Public Version Status
- New
- Public Device Record Key
- 4745945d-eb58-414e-bb2d-68d773f38949
Device Description
Solid "cold" low contrast rod with 20mm, 15mm, and 10mm ODs
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 |
|---|---|---|---|---|
| IXF | Test-Pattern, Radiographic | Radiology | 892.1940 | 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 | 00812266030628 | GS1 |