FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183511388
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
WG44-18001
Catalog number
WG44-18001
Device description
BILLEAU ear loop, 3x5mm loop
Published
2023-09-25
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
JYQLoop, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYQLoop, WireEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183511388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183511388008401835113888401835113880840183511388

GMDN Terms#

Term, Definition table
TermDefinition
Endaural wax extraction curetteA hand-held, manual, non-surgical device intended to scrape within the ear canal primarily for the extraction of ear wax during an ear/nose/throat (ENT) procedure; it is not intended for surgical scraping or manipulation of tissues. It may have various designs (e.g., serrated or blunt loop, hook, straight or curved), and may include a magnifying lens and/or light source. This is a single-use device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
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
00840183512040BR Surgical, LLCBR44-19117BR44-191172024-06-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275778Intrace USAPILOTIS TECH LLCJYQ2026-07-03
00757770409921Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00757770416196Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00757770423514Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00757770433087Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00194613033118MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613033125MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613033132MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613046132MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613089160MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613089313MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613106270MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613108007MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613112240MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00840343726430GEN2SURGIX MEDICAL LLCJYQ2025-06-16
00190776401160MillenniumAvalign Technologies, Inc.JYQ2025-06-10
00194613089320MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-03-21
00194613107994MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-03-21
10840306828116Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2025-02-12
10840306828192Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2025-01-20
10840306828239Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2025-01-20
G22313930920Medetz Surgical InstrumentsMedetz Surgical Instruments LLCJYQ2025-01-14
10840306828130Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2024-12-10
04049197309271RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197312486RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197321419RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197321457RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197321464RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197474399RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197477796RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20