SIGNASPRAY 18-04

GUDID 10855683006507

Signaspray Electrode Solution, 1 gallon bottle

PARKER LABORATORIES INC

Electrode conductive medium

• Primary Device ID: 10855683006507
• NIH Device Record Key: 167b3384-28f3-463e-89dc-06db3aa77fc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNASPRAY
• Version Model Number: ELECTRODE SOLUTION AND SKIN PREP
• Catalog Number: 18-04
• Company DUNS: 002449593
• Company Name: PARKER LABORATORIES 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 19732769500
• Email: customerservice@parkerlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855683006500 [Primary]
GS1	10855683006507 [Package]; Contains: 00855683006500; Package: BOX [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780973

FDA Product Code

• GYB: Media, Electroconductive

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: 2018-10-22
• Device Publish Date: 2016-12-06

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• 00855683006869 - Eclipse Probe Cover: 2022-01-10 A soft disposable ultrasound probe cover
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