DARCO® Wound Care Shoe System™ Insoles

Basic Information

• Brand Name: DARCO® Wound Care Shoe System™ Insoles
• Primary DI: 00609271279193
• Version / Model: WCI2
• Catalog Number: WCI2
• Company Name: DARCO INTERNATIONAL, INC.
• Labeler DUNS: 184231298
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-08
• Public Version: 1
• Public Version Date: 2023-02-16
• Public Version Status: New
• Public Device Record Key: fcb2300b-7603-4b4f-8477-27d251fafed2

Device Description

Medium

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
KNP	ORTHOSIS, CORRECTIVE SHOE	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60597	Pressure-management insole, prefabricated	A prefabricated (non-customized) device intended to be worn against the feet to reduce peak foot pressures and improve pedal circulation in a patient who has, or who is at risk of developing, peripheral vascular disease (PVD) or diabetic foot disease. It typically contains a gel-filled cushion intended to distribute force to facilitate improved blood flow within the foot. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20609271279197	GS1	Case	25	In Commercial Distribution
Primary	00609271279193	GS1