AccessGUDID - DEVICE: DHX-70H (08800021800137)

GUDID

Device Identifier (DI) Information

Brand Name: DHX-70H
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DigiMed Co., Ltd.

Primary DI Number: 08800021800137
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688265810 *Terms of Use

Device Description: The portable x-ray system, DHX-70H is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.

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?
37606	Diagnostic x-ray system generator, portable	An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a portable x-ray system, e.g., a system intended to be easily disassembled and reassembled at various locations. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). This GMDN code includes transformer and inverter generator designs. Portable x-ray generators typically comprise a control assembly (console) and high voltage transformer assembly or are of a mono-tank generator design.	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 50 and 106 KiloPascal
Handling Environment Humidity: between 45 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 21 and 40 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: 8013ecc8-405c-408c-90e9-44b5bbabba4f
Public Version Date: June 20, 2024
Public Version Number: 1
DI Record Publish Date: June 12, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
18800021800134	1	08800021800137	In Commercial Distribution	Carton box
28800021800131	2	08800021800137	In Commercial Distribution	Carton box
38800021800138	3	08800021800137	In Commercial Distribution	Carton box
48800021800135	4	08800021800137	In Commercial Distribution	Carton box
58800021800132	5	08800021800137	In Commercial Distribution	Carton box
68800021800139	6	08800021800137	In Commercial Distribution	Carton box
78800021800136	7	08800021800137	In Commercial Distribution	Carton box
88800021800133	8	08800021800137	In Commercial Distribution	Carton box