Primary Device ID | EKAV101329450 |
NIH Device Record Key | ad7ced4b-4d77-4855-9b8f-2ccb2798a0d9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DEXIS Titanium Sensor-R |
Version Model Number | 1.013.2945 |
Company DUNS | 800111106 |
Company Name | Imaging Sciences International |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | EKAV101329450 [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 | 2022-01-31 |
Device Publish Date | 2022-01-21 |
EKAV083081000 - KaVo OP 3D Vision | 2022-01-31 V8 |
EKAV083082000 - KaVo OP 3D Vision | 2022-01-31 V10 |
EKAV083083000 - KaVo OP 3D Vision | 2022-01-31 V17 |
EKAV085006210 - NOMAD Pro2 Packaged X-Ray System - R | 2022-01-31 |
EKAV085006220 - NOMAD Pro2 Packaged X-Ray System Black-R | 2022-01-31 |
EKAV101261800 - DEXIS Titanium Intraoral X-Ray Sensor | 2022-01-31 |
EKAV101261810 - KaVo IXS Size 1, Intra-Oral X-Ray Sensor | 2022-01-31 |
EKAV101261820 - KaVo IXS Size 2, Intra-Oral X-Ray Sensor | 2022-01-31 |