INTEGRA - INTEGRA is a transportable Electromagnetic (EM) - DIREX SYSTEMS CORP.

Duns Number:837501337

Device Description: INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ES INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of the following:• UCON• Integrated unit, includes the following: Shock Wave Generator (SWAG) Fluoroscopy device (X-Ray Module) Patient TableThe SWAG includes a high voltage generator module, a Reflector module, and a water module, and is located under the patient table.The Reflector is mechanically coupled to an X-Ray Tube Monoblock. The Reflector/ Monoblock assembly is attached via a U-arm to an Image Intensifier and a digital camera Module, for real time stone imaging.The U-Arm assembly is motorized, such that all three modules (Reflector, Monoblock, and Image Intensifier) move simultaneously as one piece and can be displaced electrically in all three axes, thus enabling the stone to be lined up in the therapeutic focal point.The patient and table do not move. The patient lies still on the table and only the U-Arm Assembly moves until the stone is localized.The UCON enables control over all operational aspects of the integrated unit via a software application.The operator chooses the various parameters to control the treatment including the number of shocks, intensity, frequency, etc.INTEGRA contains the necessary interfaces for ECG synchronization and ultrasonic imaging devices. INTEGRA can be used in any room equipped with the proper anesthesia equipment.

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More Product Details

Catalog Number

-

Brand Name

INTEGRA

Version/Model Number

INTEGRA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LNS

Product Code Name

Lithotriptor, Extracorporeal Shock-Wave,Urological

Device Record Status

Public Device Record Key

e58aa08c-b4e1-4064-ac59-4a8e550dc146

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIREX SYSTEMS CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5