BrainScope

GUDID 20855683006917

Skin Prep Gel 5g

PARKER LABORATORIES INC

Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium

• Primary Device ID: 20855683006917
• NIH Device Record Key: 1a25784f-5892-4cc4-8f15-950c1129970b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BrainScope
• Version Model Number: 99-1000-004
• Company DUNS: 002449593
• Company Name: PARKER LABORATORIES INC
• Device Count: 250
• 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: 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: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855683006913 [Unit of Use]
GS1	10855683006910 [Primary]
GS1	20855683006917 [Package]; Contains: 10855683006910; Package: Case [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-26
• Device Publish Date: 2023-09-18

Devices Manufactured by PARKER LABORATORIES INC

• 20855683006542 - Ultradrape: 2023-09-26 Ultrasound Guided Peripheral Intravenous Barrier and Securement Device 3.25''x5.8''
• 20855683006917 - BrainScope: 2023-09-26Skin Prep Gel 5g
• 20855683006917 - BrainScope: 2023-09-26 Skin Prep Gel 5g
• 00855683006920 - 1% KCl GEL: 2022-06-13 Bulk packed 1% KCl gel
• 00855683006883 - Alpha-Stim: 2022-03-09 Conducting solution
• 00855683006890 - Alpha-Stim: 2022-03-09 Conducting Solution - 250 ml
• 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