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

GUDID B675SILVERFLEXSOFTM1

Soft Flex Electrodes - Medium

ZETO INC

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
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

Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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 Pre-market Approvals/Notifications & deNovo

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

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