FDA UDI
In Commercial Distribution
🇺🇸 United States
CLISIS SYSTEMS
DI: 08054890480086
·
Model: WS
·
GENERAL MEDICAL MERATE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CLISIS SYSTEMS
- Primary DI
- 08054890480086
- Version / Model
- WS
- Company Name
- GENERAL MEDICAL MERATE SPA
- Labeler DUNS
- 428658934
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-11
- Public Version
- 4
- Public Version Date
- 2021-12-23
- Public Version Status
- Update
- Public Device Record Key
- fa2a84eb-dd55-4151-853c-3044bee022b1
Device Description
The wall bucky stand is used to perform exposures on the potter-bucky.
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
- No
- 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 |
|---|---|---|---|---|
| IZL | System, X-Ray, Mobile | Radiology | 892.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37631 | Portable general-purpose fluoroscopic x-ray system, analogue | An assembly of devices that comprise a portable (moved from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time analogue or analogue-to-digital techniques for image capture, display and manipulation used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested/injected x-ray contrast medium. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08054890480086 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213081 | 000 |