FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183527495
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR46-53905
Catalog number
BR46-53905
Device description
"Derlacki Mobilizer, angled tip, 6 1/4"""
Published
2024-11-26
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
KAJMobilizer, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAJMobilizer, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183527495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183527495008401835274958401835274950840183527495

GMDN Terms#

Term, Definition table
TermDefinition
ENT mobilizerA hand-held, manual, stainless steel surgical instrument with a small diameter shaft tapering from the handle typically intended to be used to remobilize the footplate of the stapes to relieve conductive hearing impairment due to otosclerosis or middle ear disease. The distal tip of the shaft is bent at a slight angle to the shaft and expands to form a small platform that is larger than the distal shaft. The distal surface of the platform is shaped into a set of small ridges or projections which can be of several geometric shapes. 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
00757770406791Bausch + LombBausch & Lomb IncorporatedKAJ2026-02-11
00757770406838Bausch + LombBausch & Lomb IncorporatedKAJ2025-07-28
00757770436231Bausch + LombBausch & Lomb IncorporatedKAJ2025-07-28
00887482042472Symmetry HoughASPEN SURGICAL PRODUCTS, INC.KAJ2024-08-20
00190776044602AvalignAvalign Technologies, Inc.KAJ2023-09-28
00190776320263MillenniumAvalign Technologies, Inc.KAJ2023-06-23
14026704805522PILLINGTELEFLEX INCORPORATEDKAJ2022-12-08
54026704805520PILLINGTELEFLEX INCORPORATEDKAJ2022-12-08
00842331165078Novo Surgical Inc. NOVO SURGICAL, INC.KAJ2022-11-13
00190660109691Ambler SurgicalAMBLER SURGICAL CORP.KAJ2021-01-04
10381780082439Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAJ2018-10-24
10885403010026V. MuellerSTERIS CORPORATIONKAJ2018-07-13
10885403009778V. MuellerSTERIS CORPORATIONKAJ2018-07-13