Soft Flat-T ZP-210-52011

GUDID B675SOFTFLATT2

Soft Flat Electrodes - Tall

ZETO INC

Analytical scalp electrode, single-use

Primary Device ID	B675SOFTFLATT2
NIH Device Record Key	506ad28a-7776-4fbd-815b-366d876217b6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Soft Flat-T
Version Model Number	ZP-210-52011
Catalog Number	ZP-210-52011
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

Customer Support Contacts

Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com
Phone	8339386334
Email	info@zetoinc.com

Device Dimensions

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B675SOFTFLATT1 [Primary]
HIBCC	B675SOFTFLATT2 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172735

FDA Product Code

GXY	Electrode, Cutaneous

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-02-02
Device Publish Date	2021-01-25

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