| Primary Device ID | EIBA9640041 |
| NIH Device Record Key | 1598d698-f92b-44db-91bb-5f4082ff24e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EDP-20 INVIVO Detector |
| Version Model Number | 964-004 |
| Company DUNS | 332599307 |
| Company Name | IBA Dosimetry GmbH |
| 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 |
| Phone | +1 901 386-2242 |
| USService@iba-group.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EIBA9640040 [Primary] |
| HIBCC | EIBA9640041 [Package] Contains: EIBA9640040 Package: Plastic Box [1 Units] In Commercial Distribution |
| IYE | Accelerator, Linear, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-09 |
| EIBA9640051 | EDP-20 3G-pSi Semiconductor detector, 5m cable |
| EIBA9640041 | EDP-20 3G-pSi Semiconductor detector, 4m cable |
| EIBA9640021 | EDP-20 3G-pSi Semiconductor detector, 2m cable |