AccessGUDID - DEVICE: OPERA SWING (08054890480031)

GUDID

Device Identifier (DI) Information

Brand Name: OPERA SWING
Version or Model: STRETCHER
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENERAL MEDICAL MERATE SPA

Primary DI Number: 08054890480031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428658934 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
15726	Radiographic stretcher	A manually-operated device consisting of a radiation translucent platform mounted on a wheeled frame designed to transport and support a recumbent patient during the acquisition of radiographic images. It may include various accessories (e.g., slots and cassette-support attachments). It is commonly used in emergencies to produce the first diagnostic images of a patient when there is little time for conventional protocol (e.g., in cases of serious patient trauma or during a large-scale catastrophe).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAA	System, X-Ray, Fluoroscopic, Image-Intensified

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140380	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 65 Centimeter
Length: 210 Centimeter

Device Record Status

Public Device Record Key: 98742f21-b323-41fb-adb1-ea9cbbbe3da4
Public Version Date: April 10, 2019
Public Version Number: 4
DI Record Publish Date: September 22, 2016