Scrip Hessco

GUDID 00812433020001

Scrip Hessco Ultrasound Gel Gallon

Scriphessco

Ultrasound contrast medium, transuterine administration

• Primary Device ID: 00812433020001
• NIH Device Record Key: 9229f3de-8582-40d4-b94d-8fedc52f08c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scrip Hessco
• Version Model Number: 663 0061
• Company DUNS: 054152269
• Company Name: Scriphessco
• 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: 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: 6307717459
• Email: lrogus@scripco.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812433020001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955246

FDA Product Code

• MUI: Media,Coupling,Ultrasound

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: 2019-10-24
• Device Publish Date: 2019-10-16

On-Brand Devices [Scrip Hessco]

• 00812433029295: Scrip Hessco Creme All Purpose Lotion 1 Gallon
• 00812433025204: Scrip Hessco Ultrasound Lotion, 1 Gallon
• 00812433023125: Scrip Hessco Basic Electrodes 2" Square, 4/Pkg
• 00812433023118: Scrip Hessco Basic Electrodes 2" Round, 4/Pkg
• 00812433023101: Scrip Hessco Reusable Electrodes 1.5" X 2.5" Oval, 4/pkg
• 00812433023095: Scrip Hessco Reusable Electrodes 1.25" Round, 4/pkg
• 00812433023088: Scrip Hessco Reusable Electrodes 2" X 3.5" 4/pkg
• 00812433023071: Scrip Hessco Reusable Electrodes 2" X 2" 4/pkg
• 00812433023064: Scrip Hessco Ultrasound Gel, 5L
• 00812433023057: Scrip Hessco Reusable Hot/Cold Packs 5" X 10.25"
• 00812433020001: Scrip Hessco Ultrasound Gel Gallon