FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183510114
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR82-11020
Catalog number
BR82-11020
Device description
Soak/Storage System, double, for rigid sinus/arthroscope and flexible rhinolaryngoscope, vapor lid, one 20" tube and one 9" tube
Published
2024-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00840183510114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183510114008401835101148401835101140840183510114

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840183531065BR Surgical, LLCBR08-36111SCSBR08-36111SCS2025-09-29
00840183531089BR Surgical, LLCBR18-48273BR18-482732025-09-29
00840183531133BR Surgical, LLCBR12-32114BR12-321142025-09-29
00840183531171BR Surgical, LLCBR18-15003BR18-150032025-09-29
00840183531201BR Surgical, LLCBR18-15238BR18-152382025-09-29
00840183529239BR Surgical, LLCBR82-11120BR82-111202025-09-05
00840183530341BR Surgical, LLCBR64-19124BR64-191242025-09-05
00840183530365BR Surgical, LLCBR64-12020BR64-120202025-09-05
00840183530532BR Surgical, LLCBR82-14109BR82-141092025-09-05
00840183530549BR Surgical, LLCBR900-7550BR900-75502025-09-05
00840183530563BR Surgical, LLCBR64-16020BR64-160202025-09-05
00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183530983BR Surgical, LLCBR99-29332BR99-293322025-09-05
00840183530990BR Surgical, LLCBR99-29333BR99-293332025-09-05
00840183530822BR Surgical, LLCBR99-29453BR99-294532025-09-03
00840183530839BR Surgical, LLCBR99-29454BR99-294542025-09-03
00840183530846BR Surgical, LLCBR99-29455BR99-294552025-09-03
00840183530853BR Surgical, LLCBR99-29456BR99-294562025-09-03
00840183530860BR Surgical, LLCBR99-29457BR99-294572025-09-03
00840183530877BR Surgical, LLCBR99-29458BR99-294582025-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183529239BR Surgical, LLCBR Surgical, LLCPHT2025-09-05
14897129991349CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-12
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
00840183528690BR Surgical, LLCBR Surgical, LLCPHT2024-10-21
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
00840183511845BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183513115BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183513511BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183513528BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183520274BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
04055207069530NARichard Wolf GmbHPHT2024-02-09