AccessGUDID - DEVICE: Corix 70 (00860010674406)

GUDID

Device Identifier (DI) Information

Brand Name: Corix 70
Version or Model: Corix 70 Plus USV
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Coramex, S.A.

Primary DI Number: 00860010674406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 821544657 *Terms of Use

Device Description: Sistema diagnóstico de rayos X dental diseñado para fijación permanente en una ubicación con objeto de generar y controlar los haces de rayos X. Registra el patrón de absorción de los haces de rayos X utilizado para exámenes radiográficos dentales generales y rutinarios que implican el diagnóstico y tratamiento (p. ej., quirúrgico o intervencionista) de afecciones de las piezas dentales, mandíbula y cavidad bucal. El sensor se coloca fuera de la boca, con el propósito de visualizar toda el área de esta y mostrar las piezas dentales, tanto en la mandíbula superior como en la inferior. Los datos proceden de imágenes analógicas y que se digitalizan posteriormente o bien de imágenes digitales.

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):	No
Over the Counter (OTC):	Yes
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?
42066	Stationary extraoral dental x-ray system, analogue	A diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed outside the mouth, the purpose being to visualize the entire mouth area showing teeth on both the upper and lower jaws. The image is from film or phosphor plate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHD	Unit, X-Ray, Extraoral With Timer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031802	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: 5e1c944f-ca9d-4c98-b513-17114ddb6813
Public Version Date: January 18, 2024
Public Version Number: 1
DI Record Publish Date: January 10, 2024