FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183517946
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR20-11214
Catalog number
BR20-11214
Device description
"BRODIE Grooved Director, buttoned, 5 3/4"""
Published
2024-05-28
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
FGMProbe And Director, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGMProbe And Director, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183517946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183517946008401835179468401835179460840183517946

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags#

DUNS number
134781207
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
00192896122826Barr ProbeSONTEC INSTRUMENTS, INC.FGM2026-03-10
00190776416201MillenniumAvalign Technologies, Inc.FGM2026-02-12
00192896122543Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00192896122550Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00190776411831MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411848MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411855MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411862MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411879MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411886MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411893MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411909MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776406325MillenniumAvalign Technologies, Inc.FGM2025-07-21
G453332312160PEAK MEDICALPeak Medical Distribution Inc.FGM2025-06-17
00190776399993MillenniumAvalign Technologies, Inc.FGM2025-06-03
04049047024422GimmiGimmi GmbHFGM2025-05-06
G4533352001180PEAK MEDICALPeak Medical Distribution Inc.FGM2025-01-20
G586G91027310Novo SurgicalNOVO SURGICAL, INC.FGM2024-10-15
04049197272230RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-09-20
04049197272247RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-09-20
04049197272254RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-09-20
04055207009840NARichard Wolf GmbHFGM2024-08-19
04055207014967NARichard Wolf GmbHFGM2024-08-19
G4533343613000PEAK MEDICALPeak Medical Distribution Inc.FGM2024-07-29
G4533343614000PEAK MEDICALPeak Medical Distribution Inc.FGM2024-07-29
G4533343614120PEAK MEDICALPeak Medical Distribution Inc.FGM2024-07-29
G4533343614340PEAK MEDICALPeak Medical Distribution Inc.FGM2024-07-29
G4533343614560PEAK MEDICALPeak Medical Distribution Inc.FGM2024-07-29
G4533343614780PEAK MEDICALPeak Medical Distribution Inc.FGM2024-07-29
04049197188333RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-06-28