AccessGUDID - DEVICE: STEPHANIX (03664049902489)

GUDID

Device Identifier (DI) Information

Brand Name: STEPHANIX
Version or Model: MOVIX DReamy_1040
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STEPHANIX

Primary DI Number: 03664049902489
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 381826536 *Terms of Use

Device Description: MOVIX DReamy is a Digital Mobile Diagnostic X-Ray System equipped with the latest generation of Flat Panel Detector (FPD). Not for mammography.

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?
37647	Mobile basic diagnostic x-ray system, digital	An assembly of devices that comprise a digital general-purpose mobile diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging and for interventional and intraoperative imaging. It consists of basic modular configurations that can be upgraded. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZL	System, X-Ray, Mobile
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212515	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
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar
Handling Environment Temperature: between 10 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 36377b59-83e7-4217-9c84-b3d7e495ee5f
Public Version Date: August 09, 2023
Public Version Number: 1
DI Record Publish Date: August 01, 2023