| Primary Device ID | 04049539105561 |
| NIH Device Record Key | 20a620e5-2dfa-4200-a625-ffc6d5c8a728 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTRABEAM SMART Spherical Applicator (40mm) |
| Version Model Number | 309120-9040-000 |
| Company DUNS | 342228620 |
| Company Name | Carl Zeiss Meditec AG |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049539105561 [Primary] |
| JAD | System, Therapeutic, X-Ray |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-22 |
| Device Publish Date | 2025-05-14 |
| 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 |
| 04049539105561 - INTRABEAM SMART Spherical Applicator (40mm) | 2025-05-22 |
| 04049539105578 - INTRABEAM SMART Spherical Applicator (45mm) | 2025-05-22 |
| 04049539064080 - INTRABEAM | 2025-04-09 The INTRABEAM 700 is a medical device used in the context of Radiation Therapy. It is used unsterile given that it shall be pla |