| 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 |