FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183528690
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR82-12027
Catalog number
BR82-12027
Device description
"Single tube only for Soak/Storage System, 1 1/4"" x 20"""
Published
2024-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHTBasin For Endoscope Reprocessing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHTBasin For Endoscope ReprocessingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183528690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183528690008401835286908401835286900840183528690

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags#

DUNS number
134781207
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840183531058BR Surgical, LLCBR46-39002BR46-390022026-07-17
00840183531546BR Surgical, LLCBR08-34411LBR08-34411L2026-07-17
00840183531553BR Surgical, LLCBR08-28118-LBR08-28118-L2026-07-17
00840183531577BR Surgical, LLCBR09-10212BR09-102122026-07-17
00840183531614BR Surgical, LLCBR08-34109SCBR08-34109SC2026-07-17
00840183531645BR Surgical, LLCBR08-93523BR08-935232026-07-17
00840183531706BR Surgical, LLCBR08-43518BR08-435182026-07-17
00840183532406BR Surgical, LLCBR08-31012SCBR08-31012SC2026-07-17
00840183532413BR Surgical, LLCBR08-82113SCBR08-82113SC2026-07-17
00840183532963BR Surgical, LLCBR46-43414BR46-434142026-07-17
00840183532970BR Surgical, LLCBR46-43415BR46-434152026-07-17
00840183531591BR Surgical, LLCBR04-19017BR04-190172026-07-16
00840183531690BR Surgical, LLCBR04-13010BR04-130102026-07-16
00840183531850BR Surgical, LLCBR08-23323BR08-233232026-07-16
00840183531966BR Surgical, LLCBR08-27015BR08-270152026-07-16
00840183532635BR Surgical, LLCBR04-17024BR04-170242026-07-16
00840183530990BR Surgical, LLCBR99-29333BR99-293332025-09-05
00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183529000BR Surgical, LLCBR900-5050-OLYSTZBR900-5050-OLYSTZ2024-11-07
00840183526986BR Surgical, LLCBR900-7110BR900-71102024-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183529239BR Surgical, LLCBR Surgical, LLCPHT2025-09-05
04897129991342CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-12
14897129991349CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-12
04897129991335CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-11
04897129991359CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-11
14897129991332CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-11
14897129991356CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-11
00840183528935BR Surgical, LLCBR Surgical, LLCPHT2024-11-07
00840183528676BR Surgical, LLCBR Surgical, LLCPHT2024-10-21
00840183528683BR Surgical, LLCBR Surgical, LLCPHT2024-10-21
00841436113083GUSCIVCO MEDICAL INSTRUMENTS CO., INC.PHT2024-09-09
20841436113087GUSCIVCO MEDICAL INSTRUMENTS CO., INC.PHT2024-09-09
00840183527167BR Surgical, LLCBR Surgical, LLCPHT2024-07-16
00840183505516BR Surgical, LLCBR Surgical, LLCPHT2024-06-24
00840183520199BR Surgical, LLCBR Surgical, LLCPHT2024-06-24
00840183525699BR Surgical, LLCBR Surgical, LLCPHT2024-06-11
00840183500146BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183500603BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183500726BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183500771BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183500795BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183501334BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183501549BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183504113BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183504182BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183505110BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183506988BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183510114BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183511845BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183513115BR Surgical, LLCBR Surgical, LLCPHT2024-06-10