AccessGUDID - DEVICE: MiniX-V (08800021800038)

GUDID

Device Identifier (DI) Information

Brand Name: MiniX-V
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DMC-07
Company Name: DigiMed Co., Ltd.

Primary DI Number: 08800021800038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688265810 *Terms of Use

Device Description: The MiniX-V is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The system helps to get sharp and clear x-ray images, and its low radiation dosage keeps patients and dentists safe from leakage radiation.

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?
44606	Hand-held intraoral dental x-ray system, digital	A diagnostic dental x-ray system designed 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. It is designed to be easily carried from location to location by a single operator. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue imaging and digitized afterwards 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 [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Storage Environment Humidity: between 5 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d8948093-ce05-4878-a65d-d907aaf82b26
Public Version Date: April 01, 2019
Public Version Number: 4
DI Record Publish Date: November 07, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
88800021800034	8	08800021800038	In Commercial Distribution	Carton Package
78800021800037	7	08800021800038	In Commercial Distribution	Carton Package
68800021800030	6	08800021800038	In Commercial Distribution	Carton Package
58800021800033	5	08800021800038	In Commercial Distribution	Carton Package
48800021800036	4	08800021800038	In Commercial Distribution	Carton Package
38800021800039	3	08800021800038	In Commercial Distribution	Carton Package
28800021800032	2	08800021800038	In Commercial Distribution	Carton Package
18800021800035	1	08800021800038	In Commercial Distribution	Carton Pakage