| Primary Device ID | 06909262061375 |
| NIH Device Record Key | b5ce0121-05e5-4cc6-883a-9eb8adf63e8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPMI® LUMERA® 300 |
| Version Model Number | 6137 |
| Company DUNS | 528182577 |
| Company Name | Carl Zeiss Suzhou Co., Ltd. |
| 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 | 06909262061375 [Primary] |
| FSO | Microscope, Surgical, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-19 |
| Device Publish Date | 2022-08-11 |
| 06909262060330 - EXTARO® 300 | 2022-08-19 |
| 06909262060347 - EXTARO® 300 | 2022-08-19 |
| 06909262060354 - EXTARO® 300 | 2022-08-19 |
| 06909262061375 - OPMI® LUMERA® 300 | 2022-08-19No description |
| 06909262061375 - OPMI® LUMERA® 300 | 2022-08-19 No description |
| 06909262100104 - EXTARO® 300 | 2022-08-19 |
| 06909262200040 - ZEISS Axio Vert | 2021-01-11 |
| 06909262200057 - ZEISS Axio Vert | 2021-01-11 |
| 06909262200064 - ZEISS Axio Vert | 2021-01-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OPMI 73267838 1173004 Live/Registered |
Carl-Zeiss-Stiftung 1980-06-25 |