AccessGUDID - DEVICE: x-mind dc (D804593151080)

GUDID

Device Identifier (DI) Information

Brand Name: x-mind dc
Version or Model: DC X-MIND 115V,SHORT CONE,II°,NO BRACKET,NO WALL PLATE (CORE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5.93.15108
Company Name: DE GÖTZEN SRL

Primary DI Number: D804593151080
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 433051802 *Terms of Use

Device Description: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device.

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?
42297	Stationary intraoral dental x-ray system, digital	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 in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.	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 [?]
K231055	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
Storage Environment Humidity: between 25 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 85 and 106 KiloPascal
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 25 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 85 and 106 KiloPascal
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 72ee8f26-2a7e-4ba1-a1a7-9951b16c3333
Public Version Date: August 08, 2024
Public Version Number: 1
DI Record Publish Date: July 31, 2024