Primary Device ID | 2500L002 |
NIH Device Record Key | ae6df488-e180-49be-b4c2-5b8fe8cb2e63 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GUARDIAN® |
Version Model Number | 2500L002 |
Catalog Number | 2500L002 |
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 |
Phone | 1-866-872-0211 |
customerservice2@ortho.microport.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | 2500L002 [Direct Marking] |
HIBCC | M6842500L0021 [Primary] |
KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-12-11 |
Device Publish Date | 2015-10-22 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GUARDIAN 98694879 not registered Live/Pending |
Guardian Products, LLC 2024-08-12 |
GUARDIAN 98674622 not registered Live/Pending |
Starrily, Inc. 2024-07-30 |
GUARDIAN 98634266 not registered Live/Pending |
Proven PCI, Inc. 2024-07-05 |
GUARDIAN 98615281 not registered Live/Pending |
Syscend, Inc. 2024-06-24 |
GUARDIAN 98589070 not registered Live/Pending |
Zero Zone, Inc. 2024-06-06 |
GUARDIAN 98543933 not registered Live/Pending |
Guardian Innovations LLC 2024-05-10 |
GUARDIAN 98543925 not registered Live/Pending |
Guardian Innovations LLC 2024-05-10 |
GUARDIAN 98516659 not registered Live/Pending |
National Oilwell Varco, L.P. 2024-04-24 |
GUARDIAN 98499919 not registered Live/Pending |
MirOil USA, LLC 2024-04-15 |
GUARDIAN 98489164 not registered Live/Pending |
Haru Partners, LLC 2024-04-08 |
GUARDIAN 98366010 not registered Live/Pending |
JBM Packaging Company 2024-01-19 |
GUARDIAN 98279959 not registered Live/Pending |
Cloverdale Paint Inc. 2023-11-21 |