DARCO® Toe-Alignment Splint™

Basic Information

• Brand Name: DARCO® Toe-Alignment Splint™
• Primary DI: 00609271039964
• Version / Model: TAS
• Catalog Number: TAS
• 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: 43ff8b2c-d845-4f57-8000-70fc3d746b53

Device Description

Universal White

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
NOC	Splint, extremity, non-inflatable, external, non-sterile	General, Plastic Surgery	878.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13544	Toe separator	A foot-worn device designed to space the toes of the foot to relieve pain, pressure/friction between toes, and/or to facilitate realignment of the toes to a natural position. It is made of soft materials (e.g., silicone, polymer gel) and may be available in a variety of forms (e.g., circular channels moulded together, small disks, half moon shape); some types are in addition intended to protect and/or reduce bunion or Tailor’s bunion formation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10609271039961	GS1	Box	12	In Commercial Distribution
Primary	00609271039964	GS1
Package	20609271039968	GS1	Case	36	In Commercial Distribution