FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183528256
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR900-75008S-CH
Catalog number
BR900-75008S-CH
Device description
ENT Ergonomic Examination Chair, Comfort series, OP-S8 (Charcoal)
Published
2024-10-25
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
00840183528256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183528256008401835282568401835282560840183528256

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840183512040BR Surgical, LLCBR44-19117BR44-191172024-06-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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M368FR601EPNONN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
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M368FR601EUCHBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
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M368IN601EPCNNNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCOBNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCONNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPNHBNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPNHNN86021INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPNHNNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18