The Electrode Store 1025

GUDID 00816022020885

Disposable Surface Electrode w/24" Colored Leads (4/strip x 10 strips)

IMPULSE MEDICAL TECHNOLOGIES, INC.

Analytical non-scalp cutaneous electrode

• Primary Device ID: 00816022020885
• NIH Device Record Key: 8b8468ef-a234-40ed-af32-3f9255d59761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Electrode Store
• Version Model Number: 1025
• Catalog Number: 1025
• Company DUNS: 080015502
• Company Name: IMPULSE MEDICAL TECHNOLOGIES, 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816022020885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020445

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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• 00816022023473: Reusable Ground Electrode, TIN GROUND/60"/1.5mm SOCKET
• 00816022023411: Reusable Bar Electrode, 9mm STEEL/LOCATOR/24" CABLE/1.5MM
• 00816022023381: EEG Single Disc Electrodes, Gold Plated with wire, 1.5mm sockets
• 00816022023374: 9mm STEEL/LOCATOR/48" BLACK/1.5mm
• 00816022023350: Reusable Bar Electrode, 9mm GOLD DISC/24" CABLE/23mm GROUND
• 00816022023336: Two Adult Finger Electrode Clips, 36" Twisted Leads, 1.5 mm sockets
• 00816022023282: PEDIATRIC FINGER CLIP/24" CABLE
• 00816022023244: 9mm STEEL/LOCATOR/42" BLACK/1.5mm
• 00816022023237: 9mm STEEL/LOCATOR/48" RED/1.5mm
• 00816022023220: 9mm TIN/42" RED/1.5mm
• 00816022023213: Reusable Ground Electrode, 37mm x 25mm LEAD GROUND/36" WIRE
• 00816022023206: 9mm TIN/42" BLACK/1.5mm
• 00816022023183: Reusable Bar Electrode, BLACK BAR/24"/SHIELDED
• 00816022023176: Ribbon Strand Electrodes, 9mm TIN/48"/14 STRAND RIBBON
• 00816022023169: 9mm STEEL/LOCATOR/42" RED/1.5mm
• 00816022023145: Reusable Bar Electrode, 9mm TIN/36"/1.5mm SOCKETS
• 00816022023138: Disposable Monopolar EMG Needle Electrodes, 6.00" EMG NEEDLE(PKG/10)
• 00816022023114: LGA-100(24)S
• 00816022023053: Reusable Bar Electrode, White, Concave 9mm Discs, 24" shielded wire; 1.5mm
• 00816022023046: SSA-06RSAF
• 00816022023039: SSA-06BSAF
• 00816022023022: MINI FINGER RINGS/24"/1.5mm SOCKETS
• 00816022022971: Reusable Ground Electrode, 25mm FLAT STEEL WITH TAB, 18" LEAD
• 00816022022964: Reusable Ground Electrode, 23mm GROUND/LOCATOR/48"/1.5mm
• 00816022022957: Reusable Ground Electrode, 32mm GROUND/48"/1.5mm SOCKET
• 00816022022933: Reusable Ground Electrode, 23mm Dia, Concave Disc, Smooth, 18" wire, 1.5mm
• 00816022022896: Ribbon Strand Electrodes, 9mm GOLD/72" RIBBON/1.5mm SOCKETS
• 00816022022797: Reusable Ground Electrode, 180mm x 25mm LEAD GROUND/36" WIRE
• 00816022022759: FINGER CLIPS/24" CABLE/1.5mm SOCKET
• 00816022022728: Reusable Bar Electrode, SHIELDED BAR, BLACK DOT DISTAL
• 00816022022704: Reusable Ground Electrode, TIN GROUND/48"/1.5mm SOCKET
• 00816022022698: Reusable Bar Electrode, 9mm TIN/42"/1.5mm SOCKETS
• 00816022022681: Reusable Ground Electrode, 23mm GROUND/LOCATOR/18"/1.5mm
• 00816022022650: 9mm TIN/24" RED/1.5mm
• 00816022022643: 6mm TIN/24" RED/1.5mm
• 00816022022629: Reusable Ground Electrode, 23mm Dia. Concave Disc, Smooth, 48" wire, 1.5mm
• 00816022022605: 6mm TIN/24" BLACK/1.5mm
• 00816022022582: 9mm STEEL/LOCATOR/24" BLACK/1.5mm
• 00816022022575: EMG Bar Electrode with 9mm Discs, 60" lead wire; 1.5 mm Socket
• 00816022022568: EEG Single Disc Electrodes, 9mm SILVER/72"(PKG-10)
• 00816022022551: 9mm STEEL/LOCATOR/24" RED/1.5mm
• 00816022022544: 9mm TIN/24" BLACK/1.5mm
• 00816022022490: Ribbon Strand Electrodes, 9mm GOLD/48"/14 STRAND RIBBON
• 00816022022469: Reusable Bar Electrode, BLACK WIRE DISTAL/24"/1.5mm
• 00816022022445: Ribbon Strand Electrodes, 9mm GOLD/120" RIBBON/1.5mm SOCKETS
• 00816022022438: Reusable Bar Electrode, 9mm STEEL/LOCATOR/42"/1.5mm SOCKETS
• 00816022022421: FINGER CLIPS/24"/1.5mm SOCKETS
• 00816022022391: Ribbon Strand Electrodes, 9mm GOLD/96" RIBBON/1.5mm SOCKETS