BIOPROTECH INC.

GUDID 28809083941011

Deep CUP EEG electrode : Disposable, EEG Cup Electrodes.

BIOPROTECH INC.

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• Primary Device ID: 28809083941011
• NIH Device Record Key: 823be613-6a38-4a39-b73a-ab4b25a6cd95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOPROTECH INC.
• Version Model Number: DEEG-A-15
• Company DUNS: 688460539
• Company Name: BIOPROTECH INC.
• Device Count: 1
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82337357720
• Email: info@protechsite.com
• Phone: +82337357720
• Email: info@protechsite.com
• Phone: +82337357720
• Email: info@protechsite.com
• Phone: +82337357720
• Email: info@protechsite.com
• Phone: +82337357720
• Email: info@protechsite.com
• Phone: +82337357720
• Email: info@protechsite.com
• Phone: +82337357720
• Email: info@protechsite.com
• Phone: +82337357720
• Email: info@protechsite.com
• Phone: +82337357720
• Email: info@protechsite.com
• Phone: +82337357720
• Email: info@protechsite.com
• Phone: +82337357720
• Email: info@protechsite.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809083941017 [Primary]
GS1	18809083941014 [Package]; Contains: 08809083941017; Package: Inner Box [50 Units]; In Commercial Distribution
GS1	28809083941011 [Package]; Contains: 18809083941014; Package: Master Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153019

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-10-18

On-Brand Devices [BIOPROTECH INC.]

• 28809083941035: Deep CUP EEG electrode : Disposable, EEG Cup Electrodes.
• 28809083941028: Deep CUP EEG electrode : Disposable, EEG Cup Electrodes.
• 28809083941011: Deep CUP EEG electrode : Disposable, EEG Cup Electrodes.
• 28809083941004: Deep CUP EEG electrode : Disposable, EEG Cup Electrodes.
• 28809083940991: SG15G: Ground, EMG Surface Electrode, 40x48mm, Cloth, Hydrogel
• 28809083940984: SG15R: 4-Disk, Cloth, Dia. 19mm, Hydrogel, EMG Surface Electrodes.