FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183519841
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR02-18091
Catalog number
BR02-18091
Device description
"ZIEGLER Head Mirror, 3 1/2"" (90mm), with leather headband"
Published
2023-03-24
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
HKFMirror, Headband, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKFMirror, Headband, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183519841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183519841008401835198418401835198410840183519841

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic head reflectorA head-worn ophthalmic device consisting of a circular concave mirror attached to a headband worn by an examiner, designed to reflect light onto the eye of a patient to allow examination of the eye and its associated structures. This is a reusable device.

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
Lot or batch
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
00757770408986Bausch + LombBausch & Lomb IncorporatedHKF2025-08-04
04045396214545clar N 55, LED 6 V, incl. lithium batteriesRudolf Riester GmbHHKF2021-07-19
M6334801100JEDMEDJEDMED INSTRUMENT COMPANYHKF2020-09-01
M6334801200JEDMEDJEDMED INSTRUMENT COMPANYHKF2020-09-01
00840183503697BR Surgical, LLCBR Surgical, LLCHKF2020-08-25
10649111324116SklarSKLAR CORPORATIONHKF2019-03-13
10649111325090SklarSKLAR CORPORATIONHKF2019-03-13
10649111325281SklarSKLAR CORPORATIONHKF2019-03-13