| Primary Device ID | 04049539104502 |
| NIH Device Record Key | 5ea2a7ed-a948-46ff-a324-3c2af9934b03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | miLOOP |
| Version Model Number | 303071-9090-000 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 04049539104496 [Primary] |
| GS1 | 04049539104502 [Package] Contains: 04049539104496 Package: [5 Units] In Commercial Distribution |
| GS1 | 04049539104519 [Package] Package: [30 Units] In Commercial Distribution |
| HNQ | Hook, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-31 |
| Device Publish Date | 2023-03-23 |
| 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 |
|---|---|
![]() MILOOP 87253471 5388005 Live/Registered |
Carl Zeiss Meditec Cataract Technology Inc. 2016-12-01 |