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.
Catalog Number
-
Brand Name
INTEGRA
Version/Model Number
INTEGRA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
LNS
Product Code Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |