FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00857556008543
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR900-2302
Catalog number
BR900-2302
Device description
BR Xenon 300 watt Light Source, automatic light sensor, with 4 port turret
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
GCTLight Source, Endoscope, Xenon Arc

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCTLight Source, Endoscope, Xenon ArcGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857556008543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857556008543008575560085438575560085430857556008543

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
00840183531430BR Surgical, LLCBR32-47202BR32-472022026-07-22
00840183531980BR Surgical, LLCBR24-67215BR24-672152026-07-22
00840183532017BR Surgical, LLCBR32-47193BR32-471932026-07-22
00840183532024BR Surgical, LLCBR32-47194BR32-471942026-07-22
00840183532031BR Surgical, LLCBR32-47195BR32-471952026-07-22
00840183532093BR Surgical, LLCBR32-38015BR32-380152026-07-22
00840183532154BR Surgical, LLCBR32-24723BR32-247232026-07-22
00840183532161BR Surgical, LLCBR32-23723BR32-237232026-07-22
00840183532178BR Surgical, LLCBR32-23022BR32-230222026-07-22
00840183531232BR Surgical, LLCBR18-21001BR18-210012026-07-21
00840183531720BR Surgical, LLCBR24-25427BR24-254272026-07-21
00840183532185BR Surgical, LLCBR18-68528BR18-685282026-07-21
00840183532192BR Surgical, LLCBR18-68516BR18-685162026-07-21
00840183532222BR Surgical, LLCBR18-27003BR18-270032026-07-21
00840183532239BR Surgical, LLCBR18-27004BR18-270042026-07-21
00840183532383BR Surgical, LLCBR20-10611BR20-106112026-07-21
00840183532475BR Surgical, LLCBR24-19018BR24-190182026-07-21
00840183532499BR Surgical, LLCBR24-32026BR24-320262026-07-21
00840183532628BR Surgical, LLCBR18-30004BR18-300042026-07-21
00840183531423BR Surgical, LLCBR10-18115ABR10-18115A2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10845854080634CONMEDConmed CorporationGCT2026-03-24
10845854041291CONMEDConmed CorporationGCT2026-03-24
00840183528607BR Surgical, LLCBR Surgical, LLCGCT2024-10-24
04048551057261n.a.Karl Storz GmbH & Co. KGGCT2024-10-16
00857556008468BR Surgical, LLCBR Surgical, LLCGCT2024-07-22
00857556008475BR Surgical, LLCBR Surgical, LLCGCT2024-07-22
10845854041307CONMEDConmed CorporationGCT2023-12-04
10845854041314CONMEDConmed CorporationGCT2023-12-04
04961333083701PENTAXHOYA CORPORATIONGCT2023-07-31
04250369707317ILOILO electronic GmbHGCT2023-06-22
04250369707324ILOILO electronic GmbHGCT2023-06-22
04250369707348ILOILO electronic GmbHGCT2023-06-22
04250369707355ILOILO electronic GmbHGCT2023-06-22
04250369707362ILOILO electronic GmbHGCT2023-06-22
04250369707379ILOILO electronic GmbHGCT2023-06-22
04250369707690ILOILO electronic GmbHGCT2023-06-22
04250369707706ILOILO electronic GmbHGCT2023-06-22
04250369707713ILOILO electronic GmbHGCT2023-06-22
04250369707720ILOILO electronic GmbHGCT2023-06-22
04250369707737ILOILO electronic GmbHGCT2023-06-22
04250369707744ILOILO electronic GmbHGCT2023-06-22
04953170400476XENON LUMPOLYMPUS MEDICAL SYSTEMS CORP.GCT2021-12-18
04953170216961EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.GCT2021-12-17
04048551166116n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551325995n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551346266n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551346273n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551346303n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551062838n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
00857580006669Light SourceGULF FIBEROPTICS, INC.GCT2017-12-01