Primary Device ID | B278RFL004E01M0 |
NIH Device Record Key | 363ecf7e-49be-48fa-8aac-58eed9dc67f8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ELEOS™ Limb Salvage System |
Version Model Number | RF-L004E-01M |
Catalog Number | RF-L004E-01M |
Company DUNS | 080254074 |
Company Name | ONKOS SURGICAL, 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 | false |
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(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com | |
Phone | +1(844)767-2766 |
customerservice@onkossurgical.com |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Width | 70 Millimeter |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B278RFL004E01M0 [Primary] |
KRO | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER |
Steralize Prior To Use | true |
Device Is Sterile | true |
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
[B278RFL004E01M0]
Radiation Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-10-05 |
Device Publish Date | 2021-09-27 |
B278TB2205E01M0 | ELEOS™ TIBIAL BASEPLATE, SIZE 5 80MM M/L |
B278TB2204E01M0 | ELEOS™ TIBIAL BASEPLATE, SIZE 4 75MM M/L |
B278TB2203E01M0 | ELEOS™ TIBIAL BASEPLATE, SIZE 3 70MM M/L |
B278TB2202E01M0 | ELEOS™ TIBIAL BASEPLATE, SIZE 2 65MM M/L |
B278TB2201E01M0 | ELEOS™ TIBIAL BASEPLATE, SIZE 1 60MM M/L |
B27800103000210 | ELEOS™ INSTRUMENTATION TRAY, 21 |
B27800103000220 | ELEOS™ INSTRUMENTATION TRAY, 22 |
B278RFR004E01M0 | ELEOS™ Resurfacing Femur, Size 4, Right |
B278RFR003E01M0 | ELEOS™ Resurfacing Femur, Size 3, Right |
B278RFR002E01M0 | ELEOS™ Resurfacing Femur, Size 2, Right |
B278RFL004E01M0 | ELEOS™ Resurfacing Femur, Size 4, Left |
B278RFL003E01M0 | ELEOS™ Resurfacing Femur, Size 3, Left |
B278RFL002E01M0 | ELEOS™ Resurfacing Femur, Size 2, Left |
B278TBTSCRW01N0 | ELEOS™ Tibial Baseplate Tapered Screw |
B278RFTSCRW01N0 | ELEOS™ Resurfacing Femur Tapered Screw |
B278THSMWOS01M0 | ELEOS™ TIBIAL HINGE W/OUT ROTATIONAL STOP ONE SIZE |
B278TBTSCRW01M0 | ELEOS™ Tibial Baseplate Tapered Screw |
B278RFTSCRW01M0 | ELEOS™ Resurfacing Femur Tapered Screw |
B278CB1720003M0 | ELEOS Segmental Stem, Cemented, 17mm x 200mm, Bowed, Fluted, 36mm Collar |
B278CB1520003M0 | ELEOS Segmental Stem, Cemented, 15mm x 200mm, Bowed, Fluted, 32mm Collar |
B278CB1320003M0 | ELEOS Segmental Stem, Cemented, 13mm x 200mm, Bowed, Fluted, 28mm Collar |
B278CB1125503M0 | ELEOS Segmental Stem, Cemented, 11mm x 255mm, Bowed, Fluted, 32mm Collar |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ELEOS 98671529 not registered Live/Pending |
Eleos Mental Systems Ltd. 2024-07-29 |
![]() ELEOS 98259952 not registered Live/Pending |
VidhcoShop LLC 2023-11-08 |
![]() ELEOS 97280289 not registered Live/Pending |
A. FLOROS IMPORTS, LLC 2022-02-23 |
![]() ELEOS 97267783 not registered Live/Pending |
Aicor Inc. 2022-02-15 |
![]() ELEOS 90738659 not registered Live/Pending |
Eleos Pharmaceuticals, LLC 2021-05-27 |
![]() ELEOS 90138174 not registered Live/Pending |
Adams, Adria Nicole 2020-08-26 |
![]() ELEOS 90032470 not registered Live/Pending |
Laserware Ltd 2020-07-02 |
![]() ELEOS 88912164 not registered Live/Pending |
Eleos Technologies, LLC 2020-05-12 |
![]() ELEOS 88912082 not registered Live/Pending |
Eleos Technologies, LLC 2020-05-12 |
![]() ELEOS 88907392 not registered Live/Pending |
Eleos Technologies, LLC 2020-05-08 |
![]() ELEOS 87336423 not registered Dead/Abandoned |
Onkos Surgical, Inc. 2017-02-15 |
![]() ELEOS 86261412 4649014 Live/Registered |
2 Harvest Holdings LLC 2014-04-24 |