gammaCore™ 40000-00103

GUDID 00855683006685

Highly Conductive Multi-Purpose Electrolyte Gel 60g

PARKER LABORATORIES INC

Electrode conductive medium

• Primary Device ID: 00855683006685
• NIH Device Record Key: f69a6e42-035a-402d-97a1-663ad6be4c7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gammaCore™
• Version Model Number: Electrolyte Gel
• Catalog Number: 40000-00103
• Company DUNS: 002449593
• Company Name: PARKER LABORATORIES INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855683006685 [Primary]

FDA Product Code

• GYB: Media, Electroconductive

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: 2019-04-23
• Device Publish Date: 2019-04-15

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• 00855683006869 - Eclipse Probe Cover: 2022-01-10 A soft disposable ultrasound probe cover
• 00855683006876 - Soterixmedical HD-Gel: 2021-11-30 High Definition Electrolyte Gel
• 10855683006859 - BioWrap: 2021-10-19 BioWrap Conductive Cream