OPERA SWING

GUDID 08054890480017

The device is a R&F remote tilting table which allows the execution of longitudinal, trasversal and oblique scanning and lateral projections without moving the patient. It is made by carbon fiber.

GENERAL MEDICAL MERATE SPA

Fluoroscopy/angiography table, powered
Primary Device ID08054890480017
NIH Device Record Key7a079fb6-da3d-4f67-b4c0-aec354c5e397
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPERA SWING
Version Model NumberX-RAY REMOTE TABLE OPERA SWING
Company DUNS428658934
Company NameGENERAL MEDICAL MERATE SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length240 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108054890480017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXJTable, Radiologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-10
Device Publish Date2016-09-22

On-Brand Devices [OPERA SWING]

08054890480048It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid sta
08054890480031The device is a stretcher in carbon fiber and it is raised via an hydraulic piston mechanism whi
08054890480017The device is a R&F remote tilting table which allows the execution of longitudinal, trasversal
08054890480000The Opera Swing is an x-ray diagnostic system and is indicated for performing general radiograph

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