GUARDIAN® 25002201

GUDID 25002201

GUARDIAN® TIBIAL SLEEVE SIZE 1

Microport Orthopedics Inc.

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 25002201
• NIH Device Record Key: 0474ee33-eac4-4e6c-a994-24116e83583b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GUARDIAN®
• Version Model Number: 25002201
• Catalog Number: 25002201
• Company DUNS: 079118736
• Company Name: Microport Orthopedics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	25002201 [Direct Marking]
HIBCC	M684250022011 [Primary]

FDA Product Code

• KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-10-22

On-Brand Devices [GUARDIAN®]

• 2500R004: GUARDIAN® RESURFACING FEMUR SIZE 4 RIGHT
• 2500R003: GUARDIAN® RESURFACING FEMUR SIZE 3 RIGHT
• 2500R002: GUARDIAN® RESURFACING FEMUR SIZE 2 RIGHT
• 2500L004: GUARDIAN® RESURFACING FEMUR SIZE 4 LEFT
• 2500L003: GUARDIAN® RESURFACING FEMUR SIZE 3 LEFT
• 2500L002: GUARDIAN® RESURFACING FEMUR SIZE 2 LEFT
• 25002205: GUARDIAN® TIBIAL SLEEVE SIZE 5
• 25002204: GUARDIAN® TIBIAL SLEEVE SIZE 4
• 25002203: GUARDIAN® TIBIAL SLEEVE SIZE 3
• 25002202: GUARDIAN® TIBIAL SLEEVE SIZE 2
• 25002114: GUARDIAN® RESURFACING FEMUR AXIAL PIN SIZE 4
• 25002113: GUARDIAN® RESURFACING FEMUR AXIAL PIN SIZE 3
• 25002112: GUARDIAN® RESURFACING FEMUR AXIAL PIN SIZE 2
• 25002111: GUARDIAN® DISTAL FEMUR AXIAL PIN
• 25002110: GUARDIAN® REDUCED RESECTION AXIAL PIN KIT
• 25002101: GUARDIAN® TIBIAL HINGE BASE W/O ROTATIONAL STOP PIN
• 25002100: GUARDIAN® TIBIAL HINGE BASE W/ ROTATIONAL STOP PIN
• 25002010: GUARDIAN® DISTAL FEMORAL AXIAL PIN KIT
• 25000220: GUARDIAN® TIBIAL SLEEVE POLY SPACER 20mm
• 25000216: GUARDIAN® TIBIAL SLEEVE POLY SPACER 16mm
• 25000212: GUARDIAN® TIBIAL SLEEVE POLY SPACER 12mm
• 25000210: GUARDIAN® TIBIAL SLEEVE POLY SPACER 10mm
• 25000208: GUARDIAN® TIBIAL SLEEVE POLY SPACER 8mm
• 25000009: GUARDIAN® DISTAL FEMUR RIGHT
• 25000007: GUARDIAN® DISTAL FEMUR LEFT
• 25002201: GUARDIAN® TIBIAL SLEEVE SIZE 1
• 2500SP22: GUARDIAN® CANAL FILLING STEM 120MM X 22MM
• 2500SP20: GUARDIAN® CANAL FILLING STEM 120MM X 20MM
• 2500SP18: GUARDIAN® CANAL FILLING STEM 120MM X 18MM
• 2500SP16: GUARDIAN® CANAL FILLING STEM 120MM X 16MM
• 2500SP14: GUARDIAN® CANAL FILLING STEM 120MM X 14MM
• 2500SP12: GUARDIAN® CANAL FILLING STEM 120MM X 12MM
• 2500CP16: GUARDIAN® CANAL FILLING STEM LG COLLAR 152MM X 16MM
• 2500CP14: GUARDIAN® CANAL FILLING STEM LG COLLAR 152MM X 14MM
• 2500CP12: GUARDIAN® CANAL FILLING STEM LG COLLAR 152MM X 12MM
• 2500CC17: GUARDIAN® CEMENTED STEM LG COLLAR 152MM X 17MM
• 2500CC15: GUARDIAN® CEMENTED STEM LG COLLAR 152MM X 15MM
• 2500CC13: GUARDIAN® CEMENTED STEM LG COLLAR 152MM X 13MM
• 2500CC11: GUARDIAN® CEMENTED STEM LG COLLAR 152MM X 11MM
• 2500BP22: GUARDIAN® BOWED CANAL FILLING STEM 152MM X 22MM
• 2500BP20: GUARDIAN® BOWED CANAL FILLING STEM 152MM X 20MM
• 2500BP18: GUARDIAN® BOWED CANAL FILLING STEM 152MM X 18MM
• 2500BP16: GUARDIAN® BOWED CANAL FILLING STEM 152MM X 16MM
• 2500BP14: GUARDIAN® BOWED CANAL FILLING STEM 152MM X 14MM
• 2500BP12: GUARDIAN® BOWED CANAL FILLING STEM 152MM X 12MM
• 25009017: GUARDIAN® TAPERED STEM 17mm X 152mm TTnm. w/POROUS COLLAR
• 25008017: GUARDIAN® TAPERED STEM 17mm X 152mm TITANIUM
• 25008015: GUARDIAN® TAPERED STEM 15mm X 152mm TITANIUM
• 25008013: GUARDIAN® TAPERED STEM 13mm X 152mm TITANIUM
• 25004013: GUARDIAN® STEM 13MM X 120MM COBALT CHROME