Guardian

Basic Information

• Brand Name: Guardian
• Primary DI: 00195411041664
• Version / Model: CP KTCS 25
• Company Name: COLLEGE PARK INDUSTRIES, INC.
• Labeler DUNS: 623191137
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-28
• Public Version: 1
• Public Version Date: 2023-07-06
• Public Version Status: New
• Public Device Record Key: 92a24b47-653a-472c-9c84-e9a154ae7572

Device Description

Knee Tube Clamp Screw, M5 x 25mm

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
ISY	Joint, Knee, External Limb Component	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64718	Mechanical-resistance external knee prosthesis	A device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for device stance/swing control is based on media-free mechanical resistance (i.e., mechanical friction/spring-actuation with no fluid or gas operating media). The device may have various designs and functional features (e.g., hinge-type, spring-control, monocentric or polycentric, semi-automatic or manual lock/brake) 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	00195411041664	GS1