FDA UDI
In Commercial Distribution
🇺🇸 United States
SEDECAL
DI: 08436046001947
·
Model: CS NOVA AT
·
SEDECAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SEDECAL
- Primary DI
- 08436046001947
- Version / Model
- CS NOVA AT
- Company Name
- SEDECAL
- Labeler DUNS
- 510948979
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-31
- Public Version
- 4
- Public Version Date
- 2021-08-09
- Public Version Status
- Update
- Public Device Record Key
- f296daad-c7a3-4c36-9283-ac1c134e9310
Device Description
Ceiling Mount X-ray tube stand
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | Radiology | 892.1770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40946 | X-ray system tube support, ceiling mounted | A component of an x-ray system (diagnostic, therapeutic, radiation therapy simulator) intended to be mounted on the ceiling to mount, support and facilitate positioning of the x-ray tube assembly (not included). It typically consists of a rack with controls. The x-ray tube assembly is attached to the rack and can be moved along the rack and/or tilted. Some designs also support the movement and positioning of an image receptor assembly (e.g., C-arm assembly). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08436046001947 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 millibar
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 millibar