FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183501136
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR900-3100
Catalog number
BR900-3100
Device description
Fiberoptic Headlight w/ 3.5mm bifurcated 9-foot cable, 20mm-110mm spot size, & deluxe headband, Wolf fitting
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
FCTHeadlight, Fiberoptic Focusing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCTHeadlight, Fiberoptic FocusingOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183501136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183501136008401835011368401835011360840183501136

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn fibreoptic lightA fibreoptic device mounted on a headband or helmet frame to convey cold light from a connected light source (not included) directly onto the field of vision during a medical or surgical procedure. It typically consists of a magnifying lens, a reflector, and a fibreoptic cable.

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

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
00860013851521Altair HI 2QED, INC.FCT2025-05-21
00860013851538Altair SAQED, INC.FCT2025-05-21
00840183529192BR Surgical, LLCBR Surgical, LLCFCT2024-12-02
00840183500559BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00840183512989BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
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00816835023981IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
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01816835023980IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
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01816835024017IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024024IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024031IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024055Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024062Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
B366HDL200FIBEROPTIC HEADLUXEclerisFCT2022-06-10
00862658000326Fiberoptics Technology IncFIBEROPTICS TECHNOLOGY, INC.FCT2021-07-26
04055207008751NARichard Wolf GmbHFCT2018-10-17
M678HL0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFCT2017-05-09
M678HLM0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFCT2017-05-09
00841645132004ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFCT2016-09-26