HCS

Basic Information

• Brand Name: HCS
• Primary DI: 00810132044335
• Version / Model: 3011SHU
• Catalog Number: 3011SHU
• Company Name: Concordance Healthcare Solutions LLC
• Labeler DUNS: 080220245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2026-03-09
• Public Version: 1
• Public Version Date: 2026-03-17
• Public Version Status: New
• Public Device Record Key: 63d22069-3765-4ebf-a1f0-ad48722a08ab

Device Description

Cover Shoe, Universal Blue, Non-Skid, Spunbound, Disposable

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15056	Shoe cover	A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810132044332	GS1	CASE	300	In Commercial Distribution
Primary	00810132044335	GS1
Unit of Use	20810132044339	GS1