| Primary Device ID | 04057748087127 |
| NIH Device Record Key | d97a352c-f4e4-4d49-9d98-5e36eb135dbd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CIRRUS HD-OCT |
| Version Model Number | CIRRUS Review Software |
| Company DUNS | 362747011 |
| Company Name | Carl Zeiss Meditec, Inc. |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04057748087127 [Primary] |
| OBO | Tomography, Optical Coherence |
| 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 | 2017-04-14 |
| 04057748087127 | The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging de |
| 04057748087097 | The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging de |
| 04057748087080 | The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining dev |
| 04057748087141 | The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining dev |