| Primary Device ID | 88800021800027 |
| NIH Device Record Key | dba0ff16-f300-4520-a67a-ff2e050b8e0b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MiniX-S |
| Version Model Number | 1 |
| Catalog Number | 1 |
| 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 |
| Phone | +82226241552 |
| fredchoi@digimed.co.kr |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800021800021 [Primary] |
| GS1 | 18800021800028 [Package] Contains: 08800021800021 Package: Carton Package [1 Units] In Commercial Distribution |
| GS1 | 28800021800025 [Package] Contains: 08800021800021 Package: Carton Package [2 Units] In Commercial Distribution |
| GS1 | 38800021800022 [Package] Contains: 08800021800021 Package: Carton Package [3 Units] In Commercial Distribution |
| GS1 | 48800021800029 [Package] Contains: 08800021800021 Package: Carton Package [4 Units] In Commercial Distribution |
| GS1 | 58800021800026 [Package] Contains: 08800021800021 Package: Carton Package [5 Units] In Commercial Distribution |
| GS1 | 68800021800023 [Package] Contains: 08800021800021 Package: Carton Package [6 Units] In Commercial Distribution |
| GS1 | 78800021800020 [Package] Contains: 08800021800021 Package: Carton Package [7 Units] In Commercial Distribution |
| GS1 | 88800021800027 [Package] Contains: 08800021800021 Package: Carton Package [8 Units] In Commercial Distribution |
| EHD | Unit, X-Ray, Extraoral With Timer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-01 |
| Device Publish Date | 2018-01-19 |
| 78800021800006 - PROX | 2023-12-25 The PROX is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians as |
| 08800021800014 - DIOX-602 | 2023-12-25 The DIOX-602 is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians |
| 18800021800110 - xm-lite | 2022-12-09 The portable x-ray system, HYBRID C70 is an x-ray generating device which is mainly designed for dental examination. So the devi |
| 88800021800027 - MiniX-S | 2019-04-01The MiniX-S is an x-ray generating device which is mainly designed for dental examination. The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high voltages, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to low voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, saving and displaying the data, a power P.C.B for supplying power to the circuit and apparatus in housing, user interface (LCD screen) and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patients and users from unnecessary exposure of radiation. The device 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. |
| 88800021800027 - MiniX-S | 2019-04-01 The MiniX-S is an x-ray generating device which is mainly designed for dental examination. The device has an x-ray tube for gene |
| 88800021800034 - MiniX-V | 2019-04-01 The MiniX-V is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians |