FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183500023
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR900-2453
Catalog number
BR900-2453
Device description
LED 50 watt Light Source w/ 4 port turret (Storz, Olympus, ACMI, Wolf)
Published
2024-07-22
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
NTNLed Light Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTNLed Light SourceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183500023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183500023008401835000238401835000230840183500023

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose light sourceA mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840183500238BR Surgical, LLCBR900-5050BR900-50502024-07-22
00840183501464BR Surgical, LLCBR900-5050-OLYBR900-5050-OLY2024-07-22
00840183501822BR Surgical, LLCBR900-3105BR900-31052024-07-22
00840183502072BR Surgical, LLCBR900-5050-ACMIBR900-5050-ACMI2024-07-22
00840183510244BR Surgical, LLCBR900-5050-ASBR900-5050-AS2024-07-22
00840183512149BR Surgical, LLCBR900-5050-ACOBR900-5050-ACO2024-07-22
00840183514891BR Surgical, LLCBR900-5050-WOLFBR900-5050-WOLF2024-07-22
00840183517861BR Surgical, LLCBR900-3103BR900-31032024-07-22
00840183522131BR Surgical, LLCBR900-5050-10BR900-5050-102024-07-22
00840183522957BR Surgical, LLCBR900-5050-OLY-6BR900-5050-OLY-62024-07-22
00840183523244BR Surgical, LLCBR900-5050-OLACBR900-5050-OLAC2024-07-22
00840183523312BR Surgical, LLCBR900-5050-PTXBR900-5050-PTX2024-07-22
00840183525491BR Surgical, LLCBR900-5050-7BR900-5050-72024-07-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817325025003iVisionMEDIMAX TECH INC.NTN2026-04-30
00851289007354FireflyFirefly GlobalNTN2025-07-18
00857556008642BR Surgical, LLCBR Surgical, LLCNTN2025-07-16
04547410513790FUJIFILMFUJIFILM CORPORATIONNTN2025-05-31
04580137732617MACHIDAMACHIDA ENDOSCOPE CO.,LTD.NTN2025-03-27
04953170458170OTV-S500 UPGRADE PACK STROBEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458231AIR MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458248MICROPHONE EXTENSION CABLEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458255HDMI CABLEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458354THROAT MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.NTN2025-02-28
06970462546221Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.NTN2025-02-28
04250480100271NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100288NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100295NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100325NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100349NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100356NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100363NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480101735NASCHÖLLY FIBEROPTIC GmbHNTN2024-12-03
04048551317488n.aKarl Storz GmbH & Co. KGNTN2024-11-29
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NTN2024-11-14
00840183528522BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183528539BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183500474BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00857556008567BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00810024670260Dragonfly Pancreaticobiliary Scope and Instrument Channel CapsCENTERPOINT SYSTEMS LLCNTN2024-07-22
00840183500047BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.NTN2024-06-11
06973031299894WhtNavi Light SourceGuangdong Optomedic Technologies, Inc.NTN2024-03-26