FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183514709
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR44-01960E
Catalog number
BR44-01960E
Device description
FARRIOR Ear Specula, oval, regular end, 6x7mm, Ebonized
Published
2023-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183514709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183514709008401835147098401835147090840183514709

GMDN Terms#

Term, Definition table
TermDefinition
Ear speculum, reusableA rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840183531201BR Surgical, LLCBR18-15238BR18-152382025-09-29
00840183529239BR Surgical, LLCBR82-11120BR82-111202025-09-05
00840183530341BR Surgical, LLCBR64-19124BR64-191242025-09-05
00840183530365BR Surgical, LLCBR64-12020BR64-120202025-09-05
00840183530532BR Surgical, LLCBR82-14109BR82-141092025-09-05
00840183530549BR Surgical, LLCBR900-7550BR900-75502025-09-05
00840183530563BR Surgical, LLCBR64-16020BR64-160202025-09-05
00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183530983BR Surgical, LLCBR99-29332BR99-293322025-09-05
00840183530990BR Surgical, LLCBR99-29333BR99-293332025-09-05
00840183530822BR Surgical, LLCBR99-29453BR99-294532025-09-03
00840183530839BR Surgical, LLCBR99-29454BR99-294542025-09-03
00840183530846BR Surgical, LLCBR99-29455BR99-294552025-09-03
00840183530853BR Surgical, LLCBR99-29456BR99-294562025-09-03
00840183530860BR Surgical, LLCBR99-29457BR99-294572025-09-03
00840183530877BR Surgical, LLCBR99-29458BR99-294582025-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329837457N/ABLACK & BLACK SURGICAL, INC.EPY2026-03-05
G04360200G0GEIZBear-Ent, LLCEPY2026-03-05
G04360201G0GEIZBear-Ent, LLCEPY2026-03-05
G04360202G0GEIZBear-Ent, LLCEPY2026-03-05
G04360203G0GEIZBear-Ent, LLCEPY2026-03-05
G04360204G0GEIZBear-Ent, LLCEPY2026-03-05
00840329837464N/ABLACK & BLACK SURGICAL, INC.EPY2026-03-04
00198506088414ELMED INCORPORATEDELMED INCORPORATEDEPY2026-02-23
00810158218925PRINCETONPrinceton Medical Group, Inc.EPY2026-02-16
00190776415846MillenniumAvalign Technologies, Inc.EPY2026-02-04
G383WM7778700SURJEXSURJEXEPY2026-01-31
G383WM7778701SURJEXSURJEXEPY2026-01-31
G383WM7778702SURJEXSURJEXEPY2026-01-31
G383WM7778703SURJEXSURJEXEPY2026-01-31
04050659354647Brünings anastignatic aural magnifierSpiggle & Theis Medizintechnik GmbHEPY2026-01-21
00810158218437PRINCETONPrinceton Medical Group, Inc.EPY2026-01-07
00810158218444PRINCETONPrinceton Medical Group, Inc.EPY2026-01-07
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