BR Surgical, LLC

COHEN intra-uterine probe, complete w/ small & big portioadaptor

Registry build 21.09.26
12manufacturers in China registered for this device type
21catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (4), Jiangsu (4), Shandong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HXB
Manufacturer City Province Registered as Device types
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30
Hangzhou Haizhu MIM Products Co., Ltd. Hangzhou Zhejiang Exporter 28
Suzhou Endophix Co., Ltd. Suzhou Jiangsu Manufacturer 17
Hangzhou Ruihao Medical Technology Ltd Hangzhou Zhejiang Contract manufacturer 12
Changzhou Xietong Industries Co., Ltd. Changzhou Jiangsu Exporter 11

Record

Regulatory record for BR Surgical, LLC
Listed by BR Surgical LLC, United States
FDA product code HXB
Device type Probe
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2024-05-28

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide, Moist Heat or Steam Sterilization
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for BR Surgical, LLC
Catalogue number Size Status
BR20-11014 In distribution
BR20-11013 In distribution
BR68-12503 In distribution
BR20-11020 In distribution
BR20-10611 In distribution
BR20-10613 In distribution
BR20-11018 In distribution
BR20-10213 In distribution
BR20-10625 In distribution
BR70-18235 In distribution
BR20-10214 In distribution
BR20-10211 In distribution
BR20-11012 In distribution
BR20-30000 In distribution
BR68-12501 In distribution
BR20-10225 In distribution
BR20-28109 In distribution
BR68-12502 In distribution
BR20-10218 In distribution
BR20-11016 In distribution
BR20-28106 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 219
Probe Depuy Spine, Inc. 190
Probe Zimmer Trabecular Metal Technology, Inc. 154
Sklar® Sklar Corporation 136
General Instruments Alphatec Spine, Inc. 112
Life Instruments Life Instrument Corp. 107
Tecomet Tecomet, Inc. 97
Tetris ST Signus Medizintechnik Gmbh 65
Invictus Alphatec Spine, Inc. 64
Medtronic Resuable Instruments Medtronic Sofamor Danek, Inc. 56
Probe Synthes Gmbh 47
Tasmin R Signus Medizintechnik Gmbh 47

Showing 12 of 330. All products under Probe

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