ELEOS™ Limb Salvage System 001-03-00021

GUDID B27800103000210

ELEOS™ INSTRUMENTATION TRAY, 21

ONKOS SURGICAL, INC.

Instrument tray, reusable

• Primary Device ID: B27800103000210
• NIH Device Record Key: 3a47633a-7ee8-4aad-bd80-88dacfcb4c0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELEOS™ Limb Salvage System
• Version Model Number: 001-03-00021
• Catalog Number: 001-03-00021
• 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

• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B27800103000210 [Primary]

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

[B27800103000210]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-03
• Device Publish Date: 2021-07-26

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• 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
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• B278RFR003E01M0: ELEOS™ Resurfacing Femur, Size 3, Right
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• B278RFL004E01M0: ELEOS™ Resurfacing Femur, Size 4, Left
• B278RFL003E01M0: ELEOS™ Resurfacing Femur, Size 3, Left
• B278RFL002E01M0: ELEOS™ Resurfacing Femur, Size 2, Left
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• B278CB1520003M0: ELEOS Segmental Stem, Cemented, 15mm x 200mm, Bowed, Fluted, 32mm Collar
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