| Primary Device ID | EKAV101289770 |
| NIH Device Record Key | 3978d050-7bf1-4db2-ab24-97b05849be74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KaVo GXS-700 Sensor Size 1 |
| Version Model Number | 1.012.8977 |
| Catalog Number | 1.012.8977 |
| Company DUNS | 144575763 |
| Company Name | GENDEX CORP. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EKAV101289770 [Primary] |
| MUH | System, x-ray, extraoral source, digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2018-10-08 |
| EKAV101291560 - KaVo GXS-700™ intraoral sensor | 2022-01-31 Size 1 Kit |
| EKAV101291570 - KaVo GXS-700™ intraoral sensor | 2022-01-31 Size 2 Kit |
| EKAV101291580 - KaVo GXS-700™ intraoral sensor | 2022-01-31 Size 1, Size 2 Kit |
| EKAV101291590 - KaVo GXS-700™ intraoral sensor | 2022-01-31 Size 1 Kit |
| EKAV101291600 - KaVo GXS-700™ intraoral sensor | 2022-01-31 Size 2 Kit |
| EKAV101291610 - KaVo GXS-700™ intraoral sensor | 2022-01-31 Size 1, Size 2 Kit |
| EKAV101305110 - KaVo GXS-700™ intraoral sensor | 2022-01-31 Size 1 Kit |
| EKAV101305120 - KaVo GXS-700™ intraoral sensor | 2022-01-31 Size 1 Kit |