FDA UDI
In Commercial Distribution
🇺🇸 United States
Orthogrid Calibration Array
DI: 00860003424865
·
Model: 1020-915-124
·
Orthogrid Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Orthogrid Calibration Array
- Primary DI
- 00860003424865
- Version / Model
- 1020-915-124
- Company Name
- Orthogrid Systems, Inc.
- Labeler DUNS
- 079674160
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-24
- Public Version
- 1
- Public Version Date
- 2025-07-02
- Public Version Status
- New
- Public Device Record Key
- 878d63c2-d5e1-4cfd-8033-2aa0a1477edf
Device Description
12-Inch Calibration Array
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
- Yes
- 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 |
|---|---|---|---|---|
| OUG | Medical Device Data System | General Hospital | 880.6310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46050 | Radiographic test pattern | A device designed to provide a test pattern appropriate for measuring, calibration, and quality control of radiographic and/or fluoroscopic systems and/or associated equipment (e.g., image intensifiers and video systems) during radiographic procedures. It typically consists of metallic screens (e.g., lead-foil, copper mesh, gold-nickel alloys) frequently sandwiched between two plastic plates; the choice of the pattern configuration, either linear or circular, and its other characteristics, depends on the particular measurement to be performed (e.g., focal spot size, resolution, modulation transfer function). The test pattern may be available in digital signal format (e.g., DVD). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860003424865 | GS1 |