| Primary Device ID | 04049539069146 |
| NIH Device Record Key | a7bd688a-4487-49e3-ab1e-e843fc9b29ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EDIS |
| Version Model Number | 6914 |
| Company DUNS | 342228620 |
| Company Name | Carl Zeiss Meditec AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
|---|---|
| GS1 | 04049539069146 [Primary] |
| OUG | Medical Device Data System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-10 |
| Device Publish Date | 2023-03-31 |
| 04049539105509 - INTRABEAM Spherical Sizer Set | 2025-06-30 The INTRABEAM Spherical Sizer Set is a sterile disposable product. It is intended to be used in the context of radiation therap |
| 04049539105516 - INTRABEAM SMART Spherical Applicator | 2025-05-22 |
| 04049539105523 - INTRABEAM SMART Spherical Applicator | 2025-05-22 |
| 04049539105530 - INTRABEAM SMART Spherical Applicator | 2025-05-22 |
| 04049539105547 - INTRABEAM SMART Spherical Applicator (35 mm) | 2025-05-22 |
| 04049539105554 - INTRABEAM SMART Spherical Applicator (35mm) | 2025-05-22 |
| 04049539105561 - INTRABEAM SMART Spherical Applicator (40mm) | 2025-05-22 |
| 04049539105578 - INTRABEAM SMART Spherical Applicator (45mm) | 2025-05-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EDIS 86340835 4707379 Live/Registered |
Electronic Drug Information Systems Solutions LLC 2014-07-17 |
![]() EDIS 85716786 4357013 Live/Registered |
EDiS Company, Inc. 2012-08-30 |
![]() EDIS 85311410 4152868 Live/Registered |
EDIS Company, Inc. 2011-05-03 |