| Primary Device ID | B667PROTOZ01 |
| NIH Device Record Key | 7b9b85c9-4fc4-4231-be0f-63a7b5e71031 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROTOZ |
| Version Model Number | 01 |
| Company DUNS | 437331574 |
| Company Name | NEXT SIGHT SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 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 |
|---|---|
| HIBCC | B667PROTOZ01 [Package] Contains: B667PROTOZ1 Package: [1 Units] In Commercial Distribution |
| HIBCC | B667PROTOZ1 [Primary] |
| HKI | Camera, Ophthalmic, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-17 |
| Device Publish Date | 2019-12-09 |
| B667PROTOZ01 - PROTOZ | 2019-12-17ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent) with different outline colors. |
| B667PROTOZ01 - PROTOZ | 2019-12-17 ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital images of a human retina without the use o |
| B667NEXY01 - NEXY | 2019-12-16 Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriati |