FDA UDI
In Commercial Distribution
🇺🇸 United States
Sectra Calibration Unit
DI: 07350092810395
·
Model: 2
·
Sectra AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sectra Calibration Unit
- Primary DI
- 07350092810395
- Version / Model
- 2
- Company Name
- Sectra AB
- Labeler DUNS
- 354117848
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-07
- Public Version
- 1
- Public Version Date
- 2022-11-15
- Public Version Status
- New
- Public Device Record Key
- 280e427c-bbba-44bf-9567-c663f49090af
Device Description
The Sectra Calibration Unit consists of calibration holders and markers. The calibration holders are intended to correctly place the calibration markers in relation to the patient during image acquisition. The calibration markers will be visible on the x-ray images and are intended to serve as scaling references. Typical users of the device are trained professionals, for example radiology technicians.
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
- Yes
- 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 |
|---|---|---|---|---|
| LHO | Instrument, Quality-Assurance, Radiologic | Radiology | 892.1940 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40614 | General-purpose diagnostic x-ray 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. It is a quality assurance (QA) device used in both calibration protocols and in subjective and quantitative evaluations of various calibration and performance characteristics of conventional and digital general-purpose x-ray imaging systems. It is also used in the assessment of the performance characteristics of 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 | 07350092810395 | GS1 |
Customer Contacts
- Phone
- +4613235206
- [email protected]