AccessGUDID - DEVICE: C015 (08053470960017)

GUDID

Device Identifier (DI) Information

Brand Name: C015
Version or Model: FP XL C015
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MICRONICA SRL

Primary DI Number: 08053470960017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428699566 *Terms of Use

Device Description: Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images

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?
40935	Diagnostic x-ray digital imaging system workstation	A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWB	Interventional Fluoroscopic X-Ray System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192182	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: 672b015a-915c-42ef-bfde-14eda41e1a63
Public Version Date: March 24, 2020
Public Version Number: 1
DI Record Publish Date: March 16, 2020