Primary Device ID | 08800018600368 |
NIH Device Record Key | a1ec12b8-3833-4ed5-b9aa-e037f6e55696 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 1717SCN |
Version Model Number | 1717SCN |
Company DUNS | 557804458 |
Company Name | Rayence 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 |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800018600368 [Primary] |
MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-05-07 |
Device Publish Date | 2016-09-16 |
08800018602195 - 0909FCC | 2024-03-29 X-ray, Fluoroscopic, image-intensified system |
08800018602201 - 0909FCC-HS | 2024-03-29 X-ray, Fluoroscopic, image-intensified system |
08800018602140 - 1417WCE | 2023-07-07 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology. |
08800018602157 - 1417WCE-HR | 2023-07-07 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology. |
08800018602164 - 1417WCE-HS | 2023-07-07 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology. |
08800018602171 - 1417WCE-GF | 2023-07-07 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology. |
08800018600924 - Vatech Clismile | 2022-06-08 This product is a orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocc |
08800018600931 - Vatech Clismile | 2022-06-08 This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat maloc |