FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183528416
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR980-9101
Catalog number
BR980-9101
Device description
"Minor Balloon Sinus Kit, (5) per box: 4-ply 17"" x 19"" Towel/Drape, 10cc Control Syringe, Neuro Sponges 1/2"" x 3"" (10 Patties/Card), 2oz Medicine Cups (3 per pack), 25ga x 3 1/2"" Spinal Needle, Half Shallow Tray, 24"" x 24"" Wrap, Sterilization Pouch"
Published
2024-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGREar, Nose, And Throat Surgical Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183528416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183528416008401835284168401835284160840183528416

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use 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
Kit
true
Lot or batch
true
Expiration date on label
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
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10198956501676CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
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10198956385795CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
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10198956492004CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956492585CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
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10198956500563CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
B098AMS177290Aligned Medical SolutionsAligned Medical SolutionsOGR2026-06-05
10198956443570CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956479609CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956490857CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956492653CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956494237CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956497009CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03