Brasseler EZX

EZX offset shaft strerilization tray,1 layer, EZX offset shaft only

Registry build 21.09.26
23manufacturers in China registered for this device type
187catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Shanghai (6), Guangdong (3). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWE
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Autocam Medical Devices (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Shaanxi Ansen Medical Technology Development Co., Ltd. Xi’An Shaanxi Contract manufacturer 7
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Showing 12 of 23. All 23 manufacturers in China registered for Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Record

Regulatory record for Brasseler EZX
Listed by Imedicom Co., Ltd., South Korea
FDA product code HWE
Device type Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class Class 1
Regulation 21 CFR 878.4820
Establishment Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-06-17
Record revised 2024-09-19 (version 5)

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, expiry date, manufacturing date, serial number
Distribution end date 2024-04-02

Catalogue Numbers

Catalogue numbers for Brasseler EZX
Catalogue number Size Status
BR EZX Kit 14 In distribution
BR EZX Kit 07 In distribution
BRXTL62B In distribution
BRITL040 In distribution
BRXTL63A In distribution
BRITL054 In distribution
BRXTL52A In distribution
BREZX501 In distribution
BREZS400 In distribution
BR EZX Kit 03 In distribution
BRITL048 In distribution
BREZX2-L01 In distribution
BREZX2-H02 In distribution
BRITL035 In distribution
BR EZX Kit 13 In distribution
BR EZX Kit 28 In distribution
BRITL060 In distribution
BR EZX Kit 32 In distribution
BRXTL46B In distribution
BRITL051 In distribution
BRXTL46A In distribution
BRXTL57A In distribution
BRITL042 In distribution
BR EZX Kit 20 In distribution
BREZX System 02 In distribution
BR EZX Kit 15 In distribution
BRXTL59A In distribution
BR EZX Kit 22 In distribution
BR EZX Kit 08 In distribution
BREZX2-B02 In distribution
BR EZX System 01 In distribution
BRXTL40B In distribution
BREZX5000 In distribution
BRXTL37A In distribution
BRXTL42A In distribution
BR EZX Kit 01 In distribution
BREZS200 In distribution
BR EZX Kit 02 In distribution
BR EZX Kit 31 In distribution
BRXTL61A In distribution
BRXTL40A In distribution
BRITL064 In distribution
BR EZX Kit 21 In distribution
BRXTL61B In distribution
BRITL039 In distribution
BREZG101 In distribution
BRXST2000M In distribution
BR EZX Kit 26 In distribution
BREZX2-S02 In distribution
BRXTL43A In distribution
BRXTL57B In distribution
BREZX510 In distribution
BRXTL43B In distribution
BR EZX System 01 In distribution
BRXTL58B In distribution
BRXTL49B In distribution
BRXTL62A In distribution
BREZT1000 In distribution
BR EZX Kit 09 In distribution
BREZT-A01 In distribution
BR EZX Kit 06 In distribution
BREZX570 In distribution
BR EZX Kit 36 In distribution
BRITL056 In distribution
BREZX500 In distribution
BRXTL64B In distribution
BR EZX Kit 05 In distribution
BREZX530 In distribution
BRITL3465 In distribution
BRXTL41B In distribution
BRXTL38B In distribution
BRXTL64A In distribution
BREZX511 In distribution
BRITL050 In distribution
BRXTL53A In distribution
BRITL043 In distribution
BRXTL44B In distribution
BRITL045 In distribution
BR EZX Kit 04 In distribution
BRXTL45B In distribution
BRXST1000A In distribution
BRXTL47A In distribution
BRXTL56A In distribution
BRXTL51B In distribution
BRITL065 In distribution
BRXTL38A In distribution
BRXTL37B In distribution
BRXTLSB3757 In distribution
BR EZX Kit 10 In distribution
BRITL037 In distribution
BRITL044 In distribution
BRITL046 In distribution
BRXST2000M In distribution
BRXTL48B In distribution
BRITL061 In distribution
BR EZX Kit 34 In distribution
BRXTL53B In distribution
BR EZX Kit 24 In distribution
BRXST1000B In distribution
BRXST2000 In distribution
BRXTLSB5865 In distribution
BR EZX Kit 30 In distribution
BRXST2000S In distribution
BRXTL45A In distribution
BREZX2-B04 In distribution
BR EZX Kit 17 In distribution
BRXTL55B In distribution
BREZX540 In distribution
BRXST-A01 In distribution
BRXTL48A In distribution
BRITL038 In distribution
BREZX2-C01 In distribution
BRXTL54B In distribution
BREZX System 03 In distribution
BR EZX Kit 23 In distribution
BREZX520 In distribution
BRITL036 In distribution
BRXTL56B In distribution
BRXTLSA5865 In distribution
BRXTL50A In distribution
BRXTL49A In distribution
BRITL059 In distribution
BREZS101 In distribution
BRXTL39B In distribution
BRXTL42B In distribution
BREZX550 In distribution
BRXTL55A In distribution
BR EZX Kit 12 In distribution
BRXTL58A In distribution
BRXTL51A In distribution
BREZB100 In distribution
BRITL041 In distribution
BRITL062 In distribution
BRXTL65B In distribution
BRXST2000 Plus In distribution
BREZX2-S01 In distribution
BRITL047 In distribution
BRITL052 In distribution
BRXTL44A In distribution
BRITL053 In distribution
BRXTL50B In distribution
BRXZT1000 In distribution
BR EZX Kit 29 In distribution
BR EZX Kit 11 In distribution
BREZX2-A01 In distribution
BREZX560 In distribution
BR EZX Kit 16 In distribution
BRITL057 In distribution
BRITL063 In distribution
BRXTL63B In distribution
BRXTLSA3765 In distribution
BR EZX Kit 18 In distribution
BRITL055 In distribution
BR EZX Kit 33 In distribution
BRXTH1000 In distribution
BREZT-A02 In distribution
BRXTL60B In distribution
BRITL049 In distribution
BRXTLSA3757 In distribution
BRXTL52B In distribution
BRXTL39A In distribution
BRXTL59B In distribution
BR EZX Kit 27 In distribution
BR EZX Kit 25 In distribution
BRXTL41A In distribution
BR EZX Kit 35 In distribution
BREZX2-B03 In distribution
BRXTL47B In distribution
BREZH100 In distribution
BREZX2-H01 In distribution
BREZH101 In distribution
BREZB200 In distribution
BREZX2-B01 In distribution
BREZS300 In distribution
BRXTL60A In distribution
BRITL034 In distribution
BREZS100 In distribution
BRXTLSB3765 In distribution
BREZH200 In distribution
BREZB100 In distribution
BRITL058 In distribution
BRXTL54A In distribution
BRXTL65A In distribution
BREZG101 Withdrawn
BREZH101 Withdrawn
BREZG100 Withdrawn
BREZH201 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
EZX Imedicom Co., Ltd. 441
Arthrex® Arthrex, Inc. 391
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment Stryker GmbH 284
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 231
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment Synthes Gmbh 226
Conserve® Microport Orthopedics Inc. 158
R3 Smith & Nephew, Inc. 147
Trigen Smith & Nephew, Inc. 139
MicroPort Microport Orthopedics Inc. 134
Made-To-Order Tornier Inc. 131
Profemur® Microport Orthopedics Inc. 129
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment Exactech, Inc. 129

Showing 12 of 1,081. All products under Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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