BetterShield

Basic Information

• Brand Name: BetterShield
• Primary DI: 10620974004285
• Version / Model: MXFS-40-FOAM
• Catalog Number: MXFS-40-FOAM
• Company Name: Southmedic Incorporated
• Labeler DUNS: 246848147
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 40
• Record Status: Published
• Publish Date: 2025-12-19
• Public Version: 1
• Public Version Date: 2025-12-29
• Public Version Status: New
• Public Device Record Key: b19ed9d8-8a62-4613-9cec-b9043cf0e30b

Device Description

Foam Face Shield

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOY	Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)	Ophthalmic	886.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11961	Face splash shield, single-use	A clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00620974004288	GS1
Primary	10620974004285	GS1

Customer Contacts

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