Soft Flex-T ZP-200-53011

GUDID B675SOFTFLEXT1

Soft Flex Electrodes - Tall

ZETO INC

Analytical scalp electrode, single-use
Primary Device IDB675SOFTFLEXT1
NIH Device Record Key73d73915-1e3b-4735-be13-fbb81b3a1cdf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoft Flex-T
Version Model NumberZP-200-53011
Catalog NumberZP-200-53011
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

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB675SOFTFLEXT0 [Unit of Use]
HIBCCB675SOFTFLEXT1 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-28
Device Publish Date2019-10-18

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