Medical Science Products

GUDID B1870390

Conductive glove, single polarity, 1/package

NEUROTRON MEDICAL, INC.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: B1870390
• NIH Device Record Key: a4798f6d-8aa1-4118-b7ec-24d903016307
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medical Science Products
• Version Model Number: PLB042-3015
• Company DUNS: 147018519
• Company Name: NEUROTRON MEDICAL, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1870390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053214

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: 2016-11-30

On-Brand Devices [Medical Science Products]

• B1870421: Conductive pad, 3 in. x 5 in., 2/package
• B1870412: Conductive pad, 2 in. x 3 in., 4/package
• B1870400: Conductive sock, single polarity, 1/package
• B1870390: Conductive glove, single polarity, 1/package
• B1870300: Conductive knee, single polarity, 1/package