GUARDIAN®

Basic Information

• Brand Name: GUARDIAN®
• Primary DI: M684250021101
• Version / Model: 25002110
• Catalog Number: 25002110
• Company Name: Microport Orthopedics Inc.
• Labeler DUNS: 079118736
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-22
• Public Version: 3
• Public Version Date: 2019-12-11
• Public Version Status: Update
• Public Device Record Key: af05854b-aa18-497e-b503-5e4e9f0ac58b

Device Description

GUARDIAN® REDUCED RESECTION AXIAL PIN KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	888.3350	2
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	888.3510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32831	Uncoated knee femur prosthesis, metallic	An implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	25002110	HIBCC
Primary	M684250021101	HIBCC

Customer Contacts

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