Health Design Low Profile Cast Boot

Basic Information

• Brand Name: Health Design Low Profile Cast Boot
• Primary DI: 00609271000537
• Version / Model: HD-CB-TP4
• Catalog Number: HD-CB-TP4
• 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: f33d8a42-bbee-4f16-b801-d2fd46e72644

Device Description

Medium/Large Black

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
IPG	SHOE, CAST	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10667	Cast boot	A boot-like device designed to be attached around a leg cast to protect and support the cast, and to assist with patient mobility. This device is generally equipped with a waterproof covering, an outer sole for walking, and closures for easy application and removal. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10609271000534	GS1	Box	12	In Commercial Distribution
Primary	00609271000537	GS1
Package	20609271000531	GS1	Case	36	In Commercial Distribution