BIOPROTECH INC.

GUDID 28809083940984

SG15R: 4-Disk, Cloth, Dia. 19mm, Hydrogel, EMG Surface Electrodes.

BIOPROTECH INC.

Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor Neuromuscular transmission motion sensor

• Primary Device ID: 28809083940984
• NIH Device Record Key: 32c0c641-ecd5-4f71-bfb5-ec9cf0c017ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOPROTECH INC.
• Version Model Number: SG15R
• 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: false
• 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
• 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	08809083940980 [Primary]
GS1	18809083940987 [Package]; Contains: 08809083940980; Package: Inner Box [25 Units]; In Commercial Distribution
GS1	28809083940984 [Package]; Contains: 18809083940987; Package: Master Case [10 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: 2023-12-18
• 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.