GAITKEEPER® Cast Shoe

Basic Information

• Brand Name: GAITKEEPER® Cast Shoe
• Primary DI: G0648317270026840
• Version / Model: 831727002684
• Company Name: POSITION HEALTH, LLC
• Labeler DUNS: 116685742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-27
• Public Version: 2
• Public Version Date: 2025-11-26
• Public Version Status: Update
• Public Device Record Key: a1b33eb0-158e-4669-a41a-ba391e0faf2e

Device Description

GAITKEEPER® Square Toe Cast Shoe. Size-Pediatric-Medium.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
32462	Cast shoe, single-use	A footwear designed to be worn over a foot that is encased in a cast in order to protect the cast material and add stability for the patient while ambulating. Its foot bed provides comfort when ambulating and it may or may not protect the toes. It is available in a variety of designs and sizes and can be typically used both indoors and outdoors; some types may be used without a cast, e.g., in the case of a toe fracture. This is a disposable device that is intended for a single-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G0648317270026840	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]