ELEOS™ Limb Salvage System 001-03-00022
GUDID B27800103000220
ELEOS™ INSTRUMENTATION TRAY, 22
ONKOS SURGICAL, INC.
Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable| Primary Device ID | B27800103000220 |
| NIH Device Record Key | b89bca4e-1681-4d31-b6de-aff1576fc23a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ELEOS™ Limb Salvage System |
| Version Model Number | 001-03-00022 |
| Catalog Number | 001-03-00022 |
| Company DUNS | 080254074 |
| Company Name | ONKOS SURGICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | true |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B27800103000220 [Primary] |
FDA Product Code
| FSM | TRAY, SURGICAL, INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
[B27800103000220]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-17 |
| Device Publish Date | 2021-08-09 |
On-Brand Devices [ELEOS™ Limb Salvage System ]
| 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 |
Trademark Results [ELEOS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 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 |
 ELEOS 85369161 4219080 Live/Registered |
Eleos Technologies, LLC 2011-07-12 |
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