BR Surgical, LLC

LOMBARDI Femoral Tibial Spreader, large, grooved pads, 22 x 13mm, opening up to 50mm, 9 1/4"

Registry build 21.09.26
34manufacturers in China registered for this device type
138catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (7), Zhejiang (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GAD
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
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74

Showing 12 of 34. All 34 manufacturers in China registered for Retractor

Record

Regulatory record for BR Surgical, LLC
Listed by BR Surgical LLC, United States
FDA product code GAD
Device type Retractor
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-02-24

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
BR18-65884 In distribution
BR18-80209 In distribution
BR18-67116 In distribution
BR18-18325 In distribution
BR18-67120 In distribution
BR18-63614 In distribution
BR40-65679 In distribution
BR18-12811 In distribution
BR18-48282 In distribution
BR18-17025C In distribution
BR18-67920BL In distribution
BR18-83333 In distribution
BR18-63510 In distribution
WG18-13121 In distribution
BR18-11018 In distribution
BR18-77000 In distribution
BR18-69401 In distribution
BR18-67016 In distribution
BR18-17040 In distribution
BR18-67920 In distribution
BR18-80314 In distribution
BR18-19140 In distribution
BR18-24215 In distribution
BR18-67713 In distribution
BR18-80230 In distribution
BR18-13121 In distribution
BR56-21475 In distribution
BR18-63410 In distribution
BR18-16117 In distribution
BR18-31202 In distribution
BR50-11123 In distribution
BR18-16017 In distribution
BR18-15002 In distribution
BR18-15004 In distribution
BR18-15876 In distribution
BR18-76501 In distribution
BR18-80218 In distribution
BR18-28001 In distribution
BR18-16812 In distribution
BR18-25138 In distribution
BR18-69402 In distribution
BR18-82406 In distribution
BR18-15001 In distribution
BR18-25222 In distribution
BR18-63714 In distribution
BR18-22002 In distribution
BR18-30201 In distribution
BR18-13121C In distribution
BR18-27003 In distribution
BR18-16825 In distribution
BR18-17050 In distribution
BR18-68528 In distribution
BR18-23335 In distribution
BR18-70020 In distribution
BR18-48401 In distribution
BR18-80211 In distribution
BR18-23400 In distribution
BR18-18750 In distribution
BR18-67014 In distribution
BR18-11312 In distribution
BR18-79100 In distribution
BR18-67114 In distribution
BR18-76425 In distribution
BR18-25100 In distribution
BR18-28004 In distribution
BR18-14001 In distribution
BR18-25238 In distribution
BR18-46907 In distribution
BR18-48273 In distribution
BR18-27004 In distribution
BR18-30310 In distribution
BR18-18123 In distribution
BR18-39700 In distribution
BR32-68081 In distribution
BR18-22104 In distribution
BR18-22004 In distribution
BR18-82606 In distribution
BR18-30002 In distribution
BR18-14000 In distribution
BR18-10105 In distribution
BR18-19162 In distribution
BR32-96000 In distribution
BR18-17115 In distribution
BR18-15238 In distribution
BR18-36450 In distribution
FG18-76418 In distribution
BR18-18738 In distribution
BR46-21185 In distribution
BR18-24398 In distribution
BR18-30004 In distribution
BR56-24220 In distribution
BR42-37613 In distribution
BR18-13519 In distribution
BR46-21183 In distribution
BR18-24214 In distribution
BR18-16217 In distribution
BR46-21182 In distribution
BR18-67821 In distribution
BR18-15864 In distribution
BR18-16806 In distribution
BR18-76503 In distribution
BR18-25024 In distribution
BR18-18125 In distribution
BR18-22102 In distribution
BR18-65413 In distribution
BR18-31204 In distribution
BR18-23421 In distribution
BR18-22103 In distribution
BR18-15231 In distribution
FG18-80214 In distribution
BR18-80214 In distribution
BR18-16817 In distribution
BR18-27103 In distribution
BR18-65110 In distribution
BR46-21184 In distribution
BR18-17109 In distribution
BR40-08520 In distribution
BR18-18122 In distribution
BR18-61042 In distribution
BR18-76718 In distribution
BR18-18019 In distribution
BR18-17025 In distribution
BR18-22003 In distribution
BR68-12602 In distribution
BR18-10107 In distribution
BR18-68516 In distribution
BR18-15964 In distribution
FG18-13121 In distribution
BR18-17020 In distribution
BR18-16810 In distribution
BR32-82725 In distribution
BR18-24316 In distribution
BR18-65010 In distribution
FG18-63510 In distribution
BR18-63511 In distribution
BR18-68416 In distribution
BR18-15003 In distribution
BR18-70022 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Thompson Thompson Surgical Instruments, Inc. 4,354
Millennium Avalign Technologies, Inc. 2,128
Surtex Surtex Instruments Ltd 1,318
Life Instruments Life Instrument Corp. 1,135
Innomed, Inc. Innomed, Inc. 1,017
Aesculap Aesculap AG 1,013
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 973
Elmed Elmed, Inc. 919
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 891
Boss Instruments Boss Instruments, Ltd. 799
gSource Gsource, LLC. 753
Sklar® Sklar Corporation 753

Showing 12 of 2,238. All products under Retractor

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