AccessGUDID - DEVICE: uDR (00810030350002)

GUDID

Device Identifier (DI) Information

Brand Name: uDR
Version or Model: uDr 596i
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: UIH TECHNOLOGIES LLC

Primary DI Number: 00810030350002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117116896 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)
KPR	System, X-Ray, Stationary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: temperature controlled room/building

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b25a18ca-8edd-4473-96c5-ccf11bb3da62
Public Version Date: May 07, 2020
Public Version Number: 1
DI Record Publish Date: April 29, 2020