Scrip Hessco

Basic Information

• Brand Name: Scrip Hessco
• Primary DI: 00812433020001
• Version / Model: 663 0061
• Company Name: Scriphessco
• Labeler DUNS: 054152269
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-16
• Public Version: 1
• Public Version Date: 2019-10-24
• Public Version Status: New
• Public Device Record Key: 9229f3de-8582-40d4-b94d-8fedc52f08c1

Device Description

Scrip Hessco Ultrasound Gel Gallon

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUI	Media,Coupling,Ultrasound	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64352	Ultrasound contrast medium, transuterine administration	A substance/formulation (e.g., solution, gel, foam) intended to be administered into the female reproductive tract, via the vagina/uterus, to enhance diagnostic ultrasound images, typically for the evaluation of the uterine cavity and/or fallopian tube patency. It may include devices for substance preparation/mixing [e.g., syringe, connector], however invasive devices for substance administration (e.g., catheter, speculum) are not included. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812433020001	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K955246	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius