| Primary Device ID | B675SOFTFLEXM1 |
| NIH Device Record Key | 18eb0478-884a-42b2-874a-9490de856ae0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Soft Flex-M |
| Version Model Number | ZP-200-52011 |
| Catalog Number | ZP-200-52011 |
| Company DUNS | 079582566 |
| Company Name | ZETO INC |
| Device Count | 25 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 833 938 6334 |
| info@zetoinc.com |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place, away from direct sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B675SOFTFLEXM0 [Unit of Use] |
| HIBCC | B675SOFTFLEXM1 [Primary] |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-28 |
| Device Publish Date | 2019-10-18 |
| B675WR190 - WR19 | 2023-03-23 EEG Headset |
| B675SILVERFLEXSOFTM1 - Silver-Flex-Soft-M | 2022-04-29 Soft Flex Electrodes - Medium |
| B675DRYFLATS02 - Dry Flat-S | 2021-02-02 Dry Flat Electrode - Short |
| B675DRYFLEXM2 - Dry Flex-M | 2021-02-02 Dry Flex Electrode - Bristle, Medium |
| B675DRYFLEXT2 - Dry Flex-T | 2021-02-02 Dry Flex Electrodes - Bristle Tall |
| B675SOFTFLATT2 - Soft Flat-T | 2021-02-02 Soft Flat Electrodes - Tall |
| B675SOFTFLATS1 - Soft Flat-S | 2019-10-28 Soft Flat Electrodes - Short |
| B675SOFTFLEXM1 - Soft Flex-M | 2019-10-28Soft Flex Electrodes - Medium |
| B675SOFTFLEXM1 - Soft Flex-M | 2019-10-28 Soft Flex Electrodes - Medium |