AccessGUDID - DEVICE: Codonics Horizon® Operating Software (00814905020052)

GUDID

Device Identifier (DI) Information

Brand Name: Codonics Horizon® Operating Software
Version or Model: 3.0.2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CODONICS INC.

Primary DI Number: 00814905020052
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101533727 *Terms of Use

Device Description: V3.0.2 Operating Software for Codonics Horizon® Imagers serial number prefix 53C, 54C, and 55C

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?
35580	Diagnostic-imaging multiformat camera	An electrically-powered camera-based imaging unit, typically using laser scanning techniques, that is designed to capture digital images created using diagnostic imaging systems, e.g., computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), gamma camera or ultrasound, and to reproduce them in variable image formats on x-ray or radiographic film. This device usually has adjustments that allow the operator to determine how many images will be recorded on one film sheet (multi-formatting). This can be typically anywhere from 1 to 128 images in multiples of two which can be recorded onto a single sheet of film.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMC	Camera, Multi Format, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021054	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: df10733d-9b4a-4e49-b8ab-5d65644681ee
Public Version Date: December 04, 2020
Public Version Number: 4
DI Record Publish Date: August 23, 2016