FDA UDI
In Commercial Distribution
🇺🇸 United States
Z-MOTION STAND
DI: 05999116186119
·
Model: 8611
·
CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő Részvénytársaság
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Z-MOTION STAND
- Primary DI
- 05999116186119
- Version / Model
- 8611
- Company Name
- CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő Részvénytársaság
- Labeler DUNS
- 520854584
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-04
- Public Version
- 1
- Public Version Date
- 2023-12-12
- Public Version Status
- New
- Public Device Record Key
- 2ccf0ac8-f48b-473e-ad1d-52e76f3d4f8f
Device Description
Z-MOTION UNIVERSAL RADIOGRAPHIC STAND
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
- 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 |
|---|---|---|---|---|
| IXY | Holder, Radiographic Cassette, Wall-Mounted | Radiology | 892.1880 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64492 | Diagnostic X-ray system image receptor floor stand | An electrically-powered component of a diagnostic x-ray system intended to be placed on the floor to mount, support, and facilitate positioning of an image receptor assembly (bucky) [not included]. It typically consists of a vertical rack with controls mounted on a base plate. The image receptor assembly is attached to the rack and can be moved along the rack and/or tilted. | No | Active |
| 37076 | X-ray system tube support, floor standing | A component of an x-ray system (diagnostic, therapeutic, radiation therapy simulator) intended to be placed on the floor to mount, support and facilitate positioning of the x-ray tube assembly (not included). It typically consists of a rack with controls mounted on a base plate. 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 | 05999116186119 | GS1 |