FDA UDI
In Commercial Distribution
🇺🇸 United States
Straight Arm System
DI: 00817100020018
·
Model: XR1000
·
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Straight Arm System
- Primary DI
- 00817100020018
- Version / Model
- XR1000
- Company Name
- KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
- Labeler DUNS
- 080269345
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- ba3a3583-af43-46d2-80b5-464f1b708b87
Device Description
Universal Radiographic Straight Arm system variable focal distance left loading Only.
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
- 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 |
|---|---|---|---|---|
| KPR | System, X-Ray, Stationary | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37645 | Stationary basic diagnostic x-ray system, digital | An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817100020018 | GS1 |
Customer Contacts
- Phone
- 1-800-366-5343
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius