BR Surgical, LLC

CleanTract™, ENT Disposable Suction Pump Kit, consisting of Air Filter Pump, Suction Tubing 10ft, and Fluid canister 1200CC, 5/box

Registry build 21.09.26
1manufacturer
17catalogue numbers in this listing

Who Else Makes It

Registered in Anhui.

Chinese manufacturers registered for FDA product code ETF
Manufacturer City Province Registered as Device types
Anhui Shiyin Photoelectric Instrument Co., Ltd. Suzhou Anhui Specification developer 18

Record

Regulatory record for BR Surgical, LLC
Listed by BR Surgical LLC, United States
FDA product code ETF
Device type Unit, Examining/Treatment, Ent
Device class Class 1
Regulation 21 CFR 874.5300
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2024-11-06

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries serial number

Catalogue Numbers

Catalogue numbers for BR Surgical, LLC
Catalogue number Size Status
BR900-7519 In distribution
BR900-7510 In distribution
BR900-7553 In distribution
BR900-7518-PED In distribution
BR900-7550 In distribution
BR900-7559 In distribution
BR980-9250 In distribution
BR900-7514 In distribution
BR900-7509 In distribution
BR900-7515 In distribution
BR980-9255 In distribution
BR900-7520 In distribution
BR980-9256 In distribution
BR900-7955 In distribution
BR900-7516 In distribution
BR900-7571 In distribution
BR900-7506 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Jedmed Jedmed Instrument Company 75
Atmos Atmos Medizintechnik Gmbh & Co. KG 18
MTI Tech Industries. Inc. 17
SMR Maxi Cabinet, Aluminum Composite, Standard-Tall, Corded Otoscopes, Canada Global Surgical Corp. 9
SMR Maxi Cabinet, Aluminum Composite, Deluxe-Tall, NO Otoscopes Global Surgical Corp. 9
Optomic Optomic España SA 7
Otopront Happersberger Otopront Gmbh 6
Disposable Hydrophobic Hepa Filter FOR Cabinet Suction Line – 6 Pack Global Surgical Corp. 4
Reliance Haag-Streit USA, Inc. 4
SMR Maxi Cabinet, Aluminum Composite, Standard, Corded Otoscopes, 220-240V, Requ Global Surgical Corp. 3
SMR Maxi Cabinet, Stainless Steel, Standard, NO Otoscopes Global Surgical Corp. 3
SMR Maxi Cabinet, Stainless Steel, Deluxe-Tall, Rechargeable Otoscopes Global Surgical Corp. 3

Showing 12 of 81. All products under Unit, Examining/Treatment, Ent

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