HCS

Basic Information

• Brand Name: HCS
• Primary DI: 00810132040047
• Version / Model: HCS4004
• Company Name: Concordance Healthcare Solutions LLC
• Labeler DUNS: 080220245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• 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: f772d523-f2be-47f8-be1a-0ca653a3d057

Device Description

Ortho Shorts, Single Use, Blue, SMS, XX Large, Latex Free

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
OEA	Non-Surgical Isolation Gown	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63872	Surgical patient underpants	A pair of underpants/shorts made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by a patient for comfort, covering, and a degree of warmth before, during, and/or after a surgical intervention; it may have an opening(s) to allow access to body orifices. It is not specifically intended for support, and is typically loose fitting to accommodate a variety of sizes; it does not include antimicrobial properties. This is a single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810132040044	GS1	Case	5	In Commercial Distribution
Primary	00810132040047	GS1
Unit of Use	20810132040041	GS1