Primary Device ID | B675SOFTFLATS1 |
NIH Device Record Key | 9be95c02-5703-4d68-8594-3accaeaeda92 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Soft Flat-S |
Version Model Number | ZP-210-51011 |
Catalog Number | ZP-210-51011 |
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 | B675SOFTFLATS0 [Unit of Use] |
HIBCC | B675SOFTFLATS1 [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 | 2019-10-28Soft Flat Electrodes - Short |
B675SOFTFLATS1 - Soft Flat-S | 2019-10-28 Soft Flat Electrodes - Short |
B675SOFTFLEXM1 - Soft Flex-M | 2019-10-28 Soft Flex Electrodes - Medium |