DEVICE: Soft Flex-M (B675SOFTFLEXM1)
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If so, send a picture of the label to
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Device Identifier (DI) Information
Soft Flex-M
ZP-200-52011
In Commercial Distribution
ZP-200-52011
ZETO, INC.
ZP-200-52011
In Commercial Distribution
ZP-200-52011
ZETO, INC.
Soft Flex Electrodes - Medium
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 11440 | Analytical scalp electrode, single-use |
A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GXY | Electrode, Cutaneous |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K172735 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Store in a cool, dry place, away from direct sunlight |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Medium |
Device Record Status
18eb0478-884a-42b2-874a-9490de856ae0
May 28, 2026
3
October 18, 2019
May 28, 2026
3
October 18, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
B675SOFTFLEXM0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
833 938 6334
info@zetoinc.com
info@zetoinc.com