Eleos™

Eleos™ Instrumentation Tray, Augment Preparation AND Trialing Instruments, Tray 13 - Complete

Registry build 21.09.26
105manufacturers in China registered for this device type
50catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FSM
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Mobility Source Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 26
Guangdong Shunde LQX Health Technology Inc. Foshan Guangdong Contract manufacturer 24

Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument

Record

Regulatory record for Eleos™
Listed by Onkos Surgical, Inc., United States
FDA product code FSM
Device type Tray, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2017-03-20
Record revised 2022-09-16 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Eleos™
Catalogue number Size Status
001-03-00007 In distribution
001-03-00005 In distribution
001-03-00012 In distribution
001-03-00018 In distribution
002-03-00014 In distribution
002-03-00008 In distribution
001-03-10009 In distribution
001-03-00014 In distribution
001-03-10013 In distribution
001-03-10003 In distribution
001-03-10014 In distribution
002-03-00011 In distribution
001-03-00017 In distribution
001-03-00004 In distribution
002-03-00007 In distribution
001-03-10011 In distribution
002-03-00004 In distribution
001-03-00029 In distribution
001-03-10008 In distribution
001-03-00015 In distribution
001-03-00020 In distribution
001-03-00009 In distribution
002-03-00009 In distribution
001-03-10001 In distribution
001-03-11200 In distribution
001-03-10005 In distribution
002-03-00002 In distribution
001-03-10010 In distribution
001-03-10007 In distribution
002-03-00013 In distribution
001-03-00013 In distribution
001-03-00028 In distribution
001-03-00010 In distribution
002-03-00005 In distribution
002-03-00006 In distribution
001-03-00011 In distribution
002-03-00010 In distribution
001-03-00019 In distribution
001-03-00008 In distribution
001-03-10006 In distribution
001-03-10012 In distribution
001-03-00002 In distribution
001-03-10004 In distribution
002-03-00012 In distribution
001-03-00001 In distribution
001-03-00016 In distribution
002-03-00021 In distribution
001-03-00006 In distribution
001-03-10002 In distribution
001-03-00003 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IMS HU-Friedy MFG Co., LLC 2,710
Tray, Surgical, Instrument Synthes Gmbh 1,052
Tray, Surgical, Instrument Medtronic Sofamor Danek, Inc. 1,012
Hu-Friedy MFG Co., LLC. HU-Friedy MFG Co., LLC 666
Aptus Medartis Inc. 588
Acumed Acumed LLC 566
Aesculap Aesculap AG 532
Sklar Sklar Corporation 465
Hu-Friedy HU-Friedy MFG Co., LLC 438
Nordent Manufacturing Inc Nordent Manufacturing Inc 429
Level ONE KLS-Martin L.P. 341
Bahadir USA Bahadir USA LLC 300

Showing 12 of 3,212. All products under Tray, Surgical, Instrument

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer