FDA UDI
In Commercial Distribution
🇺🇸 United States
OrthoScan Pulse Mini C-arm
DI: B22510000004FD0
·
Model: 1000-0004-FD
·
Ziehm-Orthoscan, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- OrthoScan Pulse Mini C-arm
- Primary DI
- B22510000004FD0
- Version / Model
- 1000-0004-FD
- Company Name
- Ziehm-Orthoscan, Inc.
- Labeler DUNS
- 196554021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-07
- Public Version
- 4
- Public Version Date
- 2023-08-02
- Public Version Status
- Update
- Public Device Record Key
- d7a9b875-2d93-4934-8685-0f34bbcf5e87
Device Description
Image-intensified fluoroscopic x-ray system, mobile
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 |
|---|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 892.1680 | 2 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | Radiology | 892.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37649 | Portable general-purpose fluoroscopic x-ray system, digital | A portable (moveable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be 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 or injected x-ray contrast medium. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B22510000004FD0 | HIBCC |
Customer Contacts
- Phone
- 480-503-8010
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133174 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 131 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 millibar