AccessGUDID - DEVICE: CLISIS SYSTEMS (08054890480062)

GUDID

Device Identifier (DI) Information

Brand Name: CLISIS SYSTEMS
Version or Model: CLISIS EXEL DRF
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENERAL MEDICAL MERATE SPA

Primary DI Number: 08054890480062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428658934 *Terms of Use

Device Description: It is an R&F remote controlled table, that can be used as a traditional R&F remote tilting table or it is possible to perform examination with detector directly in contact with the patient by using in combination the optional: Overhead Tube Suspension, Wall Stand and 2nd Wi-Fi detector.

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?
40658	Fluoroscopy/angiography table, powered	A powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXJ	Table, Radiologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213081	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: deffbe5a-1ed3-49f0-9676-45a5618d2faf
Public Version Date: December 23, 2021
Public Version Number: 4
DI Record Publish Date: July 11, 2018