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
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
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