| Primary Device ID | 04059237000747 |
| NIH Device Record Key | 631fa9f1-75fa-4c36-9bba-b2b6f54f2e1f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TOMOCAP |
| Version Model Number | N/A |
| Catalog Number | 18829 |
| Company DUNS | 329833875 |
| Company Name | Heidelberg Engineering GmbH |
| 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 | 04059237000747 [Primary] |
| GS1 | 04059237000860 [Unit of Use] |
| MXK | Device, Analysis, Anterior Segment |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-06 |
| Device Publish Date | 2020-10-29 |
| 04059237000235 - SPECTRALIS | 2025-04-01 Flex Module |
| 04059237000952 - ANTERION | 2025-02-13 |
| 04059237000723 - SPECTRALIS | 2024-10-14 |
| 04059237000792 - SPECTRALIS | 2024-10-14 |
| 04059237001027 - SPECTRALIS | 2024-10-14 |
| 04059237001034 - SPECTRALIS | 2024-10-14 |
| 04059237000938 - ANTERION | 2023-11-27 |
| 04059237000945 - ANTERION | 2023-11-27 |