AccessGUDID - DEVICE: SkyVision (10841736111724)

GUDID

Device Identifier (DI) Information

Brand Name: SkyVision
Version or Model: LINX 300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SVIS-LINX
Company Name: SKYTRON LLC

Primary DI Number: 10841736111724
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078375583 *Terms of Use

Device Description: SkyVision LINX 300 Digital Integration system includes: Medical Grade Touch Panel, Optical Router, IP addressable Control Switch and On-Board Uninterruptable Power Supply.

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?
41669	Radiology picture archiving and communication system digital archive device	A mains electricity (AC-powered) device, typically a component of a picture archiving and communication system (PACS), used for the storage and retrieval of digital radiological images and information about the images. Its integral software functions as a database for the storage and management of the radiological images and information contained therein.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMD	System, digital image communications, radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 7c96f135-abbe-4444-add8-3fb1733535cc
Public Version Date: October 25, 2018
Public Version Number: 1
DI Record Publish Date: September 24, 2018