| Primary Device ID | 04064495038012 |
| NIH Device Record Key | 9feac823-3e55-4961-9150-b5a1a2a46b05 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZEISS Optical Insert - Demo |
| Version Model Number | 39000033083 |
| Catalog Number | 39000033083 |
| Company DUNS | 344934760 |
| Company Name | Carl Zeiss Vision International 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04064495038012 [Primary] |
| HQG | Lens, spectacle, non-custom (prescription) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-12 |
| Device Publish Date | 2024-02-02 |
| 04064495038012 - ZEISS Optical Insert - Demo | 2024-02-12ZEISS Optical Insert - DEMO |
| 04064495038012 - ZEISS Optical Insert - Demo | 2024-02-12 ZEISS Optical Insert - DEMO |
| 04064495039408 - ZEISS Optical Insert- Reader | 2024-01-29 ZEISS Optical Insert- Reader |
| 04064495038029 - ZEISS Optical Inserts | 2023-07-10 ZEISS Optical Inserts |