FDA UDI
In Commercial Distribution
🇺🇸 United States
uDR
DI: 00810030350002
·
Model: uDr 596i
·
UIH TECHNOLOGIES LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- uDR
- Primary DI
- 00810030350002
- Version / Model
- uDr 596i
- Company Name
- UIH TECHNOLOGIES LLC
- Labeler DUNS
- 117116896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-29
- Public Version
- 1
- Public Version Date
- 2020-05-07
- Public Version Status
- New
- Public Device Record Key
- b25a18ca-8edd-4473-96c5-ccf11bb3da62
Device Description
The uDR 596i Radiographic system is intended to be used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
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 |
|---|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 892.1680 | 2 |
| KPR | System, X-Ray, Stationary | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37644 | Stationary basic diagnostic x-ray system, analogue | An assembly of devices that comprise a general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It is typically an x-ray film based system that use analogue or analogue-to-digital techniques for image capture and display. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (mobile imaging facility). This system consists of modular configurations that can be upgraded by the addition of hardware/software components or accessories. 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 | 00810030350002 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- temperature controlled room/building