| Primary Device ID | 04049539060228 |
| NIH Device Record Key | 312e6bb9-f746-4779-aa5b-e489659994eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KSK 150 FC |
| Version Model Number | 302303-0000-000 |
| 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 | 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 | 04049539060228 [Primary] |
| HEX | Colposcope (And Colpomicroscope) |
| 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 | 2016-10-07 |
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| 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 |