BR Surgical, LLC

PERKINS elevator (back scratcher), 1.25mm x 1.25mm blade with 135 degree curve, 6.6"

Registry build 21.09.26
5manufacturers in China registered for this device type
22catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HTE
Manufacturer City Province Registered as Device types
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
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
Huaian Tisurg Medical Instruments Co., Ltd. Huaian Jiangsu Contract manufacturer 22

Record

Regulatory record for BR Surgical, LLC
Listed by BR Surgical LLC, United States
FDA product code HTE
Device type Elevator
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2024-02-06

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
BR32-81108 In distribution
BR44-70380 In distribution
BR32-75802 In distribution
BR32-75801 In distribution
BR32-75225 In distribution
BR44-80516 In distribution
BR32-75912 In distribution
BR44-72441 In distribution
BR44-72443 In distribution
BR32-75213 In distribution
BR46-41216 In distribution
BR44-80718 In distribution
BR32-80724 In distribution
BR44-80919 In distribution
BR32-75906 In distribution
BR74-74213 In distribution
BR44-72442 In distribution
BR32-74913 In distribution
BR40-15804 In distribution
BR74-74011 In distribution
BR44-80720 In distribution
BR74-74012 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Life Instruments Life Instrument Corp. 383
General Instruments Alphatec Spine, Inc. 326
Timberline Lateral Fusion System Highridge Medical, LLC 209
Battalion Alphatec Spine, Inc. 152
IdentiTi Alphatec Spine, Inc. 110
Intervertebral Disc Preparation Instruments Alphatec Spine, Inc. 103
Orthomed Ortho-MED, Inc. 100
Tecomet Tecomet, Inc. 88
Innomed, Inc. Innomed, Inc. 85
General Instrument Alphatec Spine, Inc. 85
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 71
Elmed Elmed, Inc. 67

Showing 12 of 246. All products under Elevator

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