uDR

GUDID 00810030350002

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.

UIH TECHNOLOGIES LLC

Stationary basic diagnostic x-ray system, analogue

• Primary Device ID: 00810030350002
• NIH Device Record Key: b25a18ca-8edd-4473-96c5-ccf11bb3da62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uDR
• Version Model Number: uDr 596i
• Company DUNS: 117116896
• Company Name: UIH TECHNOLOGIES LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *temperature controlled room/building

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810030350002 [Primary]

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-07
• Device Publish Date: 2020-04-29

Devices Manufactured by UIH TECHNOLOGIES LLC

• 00810030350095 - uMI VM: 2021-11-29 The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is int
• 00810030350088 - uMI: 2021-06-14 The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is int
• 00810030350019 - uCT: 2020-12-28 The uCT Computed Tomography X-ray System uCT 530 is a computed tomography X-ray system intended to produce cross-sectional image
• 00810030350026 - uCT: 2020-12-28 The uCT Computed Tomography X-ray System uCT 550 is a computed tomography X-ray system intended to produce cross-sectional image
• 00810030350040 - uCT: 2020-05-21 The uCT Computed Tomography X-ray System uCT 780 is a computed tomography x-ray system intended to produce cross-sectional image
• 00810030350033 - uCT: 2020-05-11 The uCT Computed Tomography X-ray System uCT 760 is a computed tomography x-ray system intended to produce cross-sectional image
• 00810030350057 - uMR: 2020-05-11 The uMR 570 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, cor
• 00810030350002 - uDR: 2020-05-07The 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.
• 00810030350002 - uDR: 2020-05-07 The uDR 596i Radiographic system is intended to be used by a qualified/trained doctor or technician on both adult and pediatric