OPERA SWING

GUDID 08054890480031

The device is a stretcher in carbon fiber and it is raised via an hydraulic piston mechanism which is controlled by a foot-pedal.

GENERAL MEDICAL MERATE SPA

Radiographic stretcher
Primary Device ID08054890480031
NIH Device Record Key98742f21-b323-41fb-adb1-ea9cbbbe3da4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPERA SWING
Version Model NumberSTRETCHER
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

Length210 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108054890480031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAASystem, X-Ray, Fluoroscopic, Image-Intensified

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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