FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183530372
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR900-7528
Catalog number
BR900-7528
Device description
Left Brake Pin with Adjustment Handle for BR900-75004 (OP-S4) ENT Chair
Published
2025-07-16
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
GBBChair, Surgical, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBBChair, Surgical, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183530372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183530372008401835303728401835303720840183530372

GMDN Terms#

Term, Definition table
TermDefinition
ENT chair, electricA mains electricity (AC-powered) device designed to support a patient in a seated position to facilitate ear, nose, throat (i.e., ENT) examination, treatment, and/or minor surgery. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to standard positions. Devices intended for ENT examination and/or treatment (e.g., otoscopes, laryngoscopes) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units.

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

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
00198506091568ELMED INCORPORATEDELMED INCORPORATEDGBB2026-06-08
08600155032011DexorRappo Robotics, Inc.GBB2026-05-16
M368EPC500ST1HAUSTEDGF HEALTH PRODUCTS, INC.GBB2026-04-09
M368EPC500STMB1HAUSTEDGF HEALTH PRODUCTS, INC.GBB2026-04-09
05999569240048Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569240079Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569242202Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569242219Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569244213Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569245005DiacareDIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
07350136560217Pedal platformRini Ergoteknik ABGBB2026-03-24
M368ESC2EYESTMBX1HAUSTEDGF HEALTH PRODUCTS, INC.GBB2026-02-02
04049199006277SCHMITZSCHMITZ medical GmbHGBB2025-09-17
04049199006284SCHMITZSCHMITZ medical GmbHGBB2025-09-17
04049199006291SCHMITZSCHMITZ medical GmbHGBB2025-09-17
M368ESC2EYESTMB1HaustedGF HEALTH PRODUCTS, INC.GBB2025-08-21
04049199011608SCHMITZSCHMITZ medical GmbHGBB2025-08-14
00840183530389BR Surgical, LLCBR Surgical, LLCGBB2025-07-16
00841709122958MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709122965MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709122972MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709122989MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709122996MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123009MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123016MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123023MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123030MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123047MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123054MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123061MidmarkMIDMARK CORPORATIONGBB2025-06-04