FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183529758
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR42-60201
Catalog number
BR42-60201
Device description
WILDER Lacrimal Dilator, #1, fine taper
Published
2025-02-14
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
HNWDilator, Lachrymal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNWDilator, LachrymalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183529758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183529758008401835297588401835297580840183529758

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal dilator, reusableA hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable 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
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
00190776421823MillenniumAvalign Technologies, Inc.HNW2026-06-24
04251047934155Gerten Dilator for the Easy Liquid Bubble DMEKA1 Medical GmbHHNW2026-06-09
00810158214538PRINCETONPrinceton Medical Group, Inc.HNW2026-04-21
00840319758892Hayden MedicalHayden Medical, Inc.HNW2026-03-31
00041533986560Bruder KarpeckiThe Hilsinger Company Parent, LlcHNW2025-11-21
00190776411619MillenniumAvalign Technologies, Inc.HNW2025-09-24
00194613010836MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010867MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010874MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613051501MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613083168MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00190776400873MillenniumAvalign Technologies, Inc.HNW2025-06-05
G412PH60850MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH6085T0MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60860MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60870MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60880MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60890MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60900MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60910MR PHACOCrestpoint Management LimitedHNW2025-05-27
00810158215191PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
00810158215207PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
00810158215214PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
G2231132500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNW2025-05-13
00810158215078PRINCETONPrinceton Medical Group, Inc.HNW2025-05-06
00194613010904MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-03-21
00810158214514PRINCETONPrinceton Medical Group, Inc.HNW2025-03-13
00810158214521PRINCETONPrinceton Medical Group, Inc.HNW2025-03-13
00810158214194PRINCETONPrinceton Medical Group, Inc.HNW2025-01-27
00757770410668Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20