Odyssey K3

Basic Information

• Brand Name: Odyssey K3
• Primary DI: 00195411040100
• Version / Model: ODK3 RCEN 29 D5
• Company Name: COLLEGE PARK INDUSTRIES, INC.
• Labeler DUNS: 623191137
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-18
• Public Version: 1
• Public Version Date: 2023-09-26
• Public Version Status: New
• Public Device Record Key: 909b98d6-abf1-4bcd-bfbf-0bec84ef0b6f

Device Description

Odyssey K3 Foot, Right, Caucasian, Endo IP, 29cm, Category 5

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• 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
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64724	Hydraulic/pneumatic external ankle-foot prosthesis	A device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion motion control is based on hydraulics and/or pneumatics (e.g., using fixed fluid orifices, or needle or servo valves). It responds to changes in motion by providing variable damping through progressive adjustments [i.e. over several steps] in motion resistance. It may have various designs and functional features (e.g., integrated carbon fibre blade, split/sandal toe, adjustable heel height) for support during a variety of activities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195411040100	GS1

Customer Contacts

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