Silver-Flex-Soft-M ZP-200-32011

GUDID B675SILVERFLEXSOFTM1

Soft Flex Electrodes - Medium

ZETO INC

Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use
Primary Device IDB675SILVERFLEXSOFTM1
NIH Device Record Keyda5985c2-ff17-48ab-a314-68679f563aba
Commercial Distribution Discontinuation2019-08-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSilver-Flex-Soft-M
Version Model NumberZP-200-32011
Catalog NumberZP-200-32011
Company DUNS079582566
Company NameZETO INC
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com
Phone833 938 6334
Emailinfo@zetoinc.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place, away from direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB675SILVERFLEXSOFTM0 [Unit of Use]
HIBCCB675SILVERFLEXSOFTM1 [Primary]

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-04-29
Device Publish Date2019-08-15

Devices Manufactured by ZETO INC

B675WR190 - WR192023-03-23 EEG Headset
B675SILVERFLEXSOFTM1 - Silver-Flex-Soft-M2022-04-29Soft Flex Electrodes - Medium
B675SILVERFLEXSOFTM1 - Silver-Flex-Soft-M2022-04-29 Soft Flex Electrodes - Medium
B675DRYFLATS02 - Dry Flat-S2021-02-02 Dry Flat Electrode - Short
B675DRYFLEXM2 - Dry Flex-M2021-02-02 Dry Flex Electrode - Bristle, Medium
B675DRYFLEXT2 - Dry Flex-T2021-02-02 Dry Flex Electrodes - Bristle Tall
B675SOFTFLATT2 - Soft Flat-T2021-02-02 Soft Flat Electrodes - Tall
B675SOFTFLATS1 - Soft Flat-S 2019-10-28 Soft Flat Electrodes - Short
B675SOFTFLEXM1 - Soft Flex-M2019-10-28 Soft Flex Electrodes - Medium
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