HCS

Basic Information

• Brand Name: HCS
• Primary DI: 00810132040962
• Version / Model: HCS3012
• Company Name: Concordance Healthcare Solutions LLC
• Labeler DUNS: 080220245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-04-21
• Public Version: 1
• Public Version Date: 2023-05-01
• Public Version Status: New
• Public Device Record Key: 9e8fae76-29fa-4e75-b66d-cc9df9e1199c

Device Description

Shoe Cover, Blue, SBPP, Non-conductive, Non-Skid, X-Large

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: No
• 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	10810132040969	GS1	Case	3	In Commercial Distribution
Primary	00810132040962	GS1
Unit of Use	20810132040966	GS1