| Primary Device ID | 04057748087141 | 
| NIH Device Record Key | dbae982e-d19d-44e1-8b1c-857a398c99f1 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | CIRRUS HD-OCT | 
| Version Model Number | 6000 | 
| 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 | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04057748087141 [Primary] | 
| OBO | Tomography, Optical Coherence | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-11-11 | 
| Device Publish Date | 2019-11-01 | 
| 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 |