IHN

Basic Information

• Brand Name: IHN
• Primary DI: 00860011457800
• Version / Model: 40015
• Company Name: IHN, Inc.
• Labeler DUNS: 183692342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-07
• Public Version: 1
• Public Version Date: 2024-02-15
• Public Version Status: New
• Public Device Record Key: 125ff3e7-419e-4375-b67b-a0ec3c6de609

Device Description

3x10=0 Full Extension Knee Device

Device Characteristics

• Single Use: No
• 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
HST	Apparatus, Traction, Non-Powered	Orthopedic	888.5850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63464	Lower limb sliding exerciser, non-powered	A non-powered device intended to encourage active movement of a patient’s lower limb(s) by assisting linear (or circular) movement of the foot, by flexion/extension at the knee, for rehabilitation and/or to help prevent deep vein thrombosis. It can be in the form of pad worn on the heel for sliding on a floor (or other smooth surface), or a frame with a moveable section placed on a bed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860011457807	GS1	Box	2	In Commercial Distribution
Primary	00860011457800	GS1
Package	20860011457804	GS1	Box	16	In Commercial Distribution

Customer Contacts

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