FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183500559
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR900-3300
Catalog number
BR900-3300
Device description
Fiberoptic Headlight w/ 3.5mm bifurcated 9-foot cable, 20mm-110mm spot size, & deluxe headband, Storz adapter
Published
2024-07-22
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
FCTHeadlight, Fiberoptic Focusing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCTHeadlight, Fiberoptic FocusingOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183500559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183500559008401835005598401835005590840183500559

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00860013851521Altair HI 2QED, INC.FCT2025-05-21
00860013851538Altair SAQED, INC.FCT2025-05-21
00840183529192BR Surgical, LLCBR Surgical, LLCFCT2024-12-02
00840183501136BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00840183512989BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00816835023950IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023966IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023973IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023980IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023997IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
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
00841645132011ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFCT2016-09-26
00841645132028ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFCT2016-09-26
00851321006116Gemini PlusVITALCOR, INCFCT2016-09-16