AccessGUDID - DEVICE: 3DSCOPE (00863499000322)

GUDID

Device Identifier (DI) Information

Brand Name: 3DSCOPE
Version or Model: 3DSCOPE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DIREX SYSTEMS CORP.

Primary DI Number: 00863499000322
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 837501337 *Terms of Use

Device Description: 3Dscope is intended for acquisition, processing and display of fluoroscopy images. It can be also used together with an extra-corporeal shockwave lithotripsy. 3Dscope enables: • Visualization of various objects on fluoroscopy images (for example, kidney stones). • Generation and storage of patient records. • Comparing images obtained at different times. • Generation and management of patient data files and fluoroscopy images. The device is composed of the following units: • Workstation Console, which contains the application software for the system indicators and image display of the following:  System status  Fluoroscopy images • Gantry unit, which contains he HF X-Ray generator, image intensifier and digital camera. It performs the following:  Generator control  Image initial processing  Data transfer to the Workstation console.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
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?
35821	Fluoroscopic x-ray system video image recording unit	An assembly of devices that are part of a fluoroscopic x-ray system and specifically designed to display x-ray images in real-time. It is often referred to as an x-ray imaging chain. It includes a video camera [charge-coupled device (CCD) or tube based], a video signal generator, and cabling used to convert the analogue image taken from the output raster of the x-ray image intensifier and to display it on one or more image display monitors [visual display unit (VDU)] for immediate viewing.	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 [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 07a4d84d-53df-405e-a006-1c1205d2ee21
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 01, 2016