MiniX-V DMC-07

GUDID 88800021800034

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.

DigiMed Co., Ltd.

Hand-held intraoral dental x-ray system, digital

• Primary Device ID: 88800021800034
• NIH Device Record Key: d8948093-ce05-4878-a65d-d907aaf82b26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniX-V
• Version Model Number: 1
• Catalog Number: DMC-07
• Company DUNS: 688265810
• Company Name: DigiMed Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82226241552
• Email: fredchoi@digimede.co.kr

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800021800038 [Primary]
GS1	18800021800035 [Package]; Contains: 08800021800038; Package: Carton Pakage [1 Units]; In Commercial Distribution
GS1	28800021800032 [Package]; Contains: 08800021800038; Package: Carton Package [2 Units]; In Commercial Distribution
GS1	38800021800039 [Package]; Contains: 08800021800038; Package: Carton Package [3 Units]; In Commercial Distribution
GS1	48800021800036 [Package]; Contains: 08800021800038; Package: Carton Package [4 Units]; In Commercial Distribution
GS1	58800021800033 [Package]; Contains: 08800021800038; Package: Carton Package [5 Units]; In Commercial Distribution
GS1	68800021800030 [Package]; Contains: 08800021800038; Package: Carton Package [6 Units]; In Commercial Distribution
GS1	78800021800037 [Package]; Contains: 08800021800038; Package: Carton Package [7 Units]; In Commercial Distribution
GS1	88800021800034 [Package]; Contains: 08800021800038; Package: Carton Package [8 Units]; In Commercial Distribution

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-01
• Device Publish Date: 2016-11-07

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