HCS

Basic Information

• Brand Name: HCS
• Primary DI: 00810132044274
• Version / Model: 99001
• Company Name: Concordance Healthcare Solutions LLC
• Labeler DUNS: 080220245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2025-03-05
• Public Version: 2
• Public Version Date: 2025-04-08
• Public Version Status: Update
• Public Device Record Key: e7c63edb-004a-43d1-8cd4-c9181f081e5c

Device Description

Cotton Ball, Medium, Non-Sterile, 100% cotton

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
EFN	Cotton, Roll	Dental	872.6050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44971	General-purpose surgical sponge	A non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. 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	20810132044278	GS1
Primary	00810132044274	GS1
Package	10810132044271	GS1	CASE	4000	In Commercial Distribution