FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183527327
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR46-61021
Catalog number
BR46-61021
Device description
"Sinus Frontal Curette curved, 75° angle, 2mm x 5mm, 7 1/2"""
Published
2024-07-16
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
KAPCurette, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAPCurette, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183527327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183527327008401835273278401835273270840183527327

GMDN Terms#

Term, Definition table
TermDefinition
Paranasal sinus curetteA slender, hand-held, manual surgical instrument designed for scraping and/or excising tissue from one of the paranasal sinuses (i.e., frontal, sphenoidal, ethmoidal, maxillary). The distal end of the instrument is finished in an appropriate shape (e.g., cup-, ring-, spoon-like) according to the procedure to be performed; the device is typically made of high-grade stainless steel and is available in a variety of shapes and sizes. 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
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00840183531706BR Surgical, LLCBR08-43518BR08-435182026-07-17
00840183532406BR Surgical, LLCBR08-31012SCBR08-31012SC2026-07-17
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00840183531850BR Surgical, LLCBR08-23323BR08-233232026-07-16
00840183531966BR Surgical, LLCBR08-27015BR08-270152026-07-16
00840183532635BR Surgical, LLCBR04-17024BR04-170242026-07-16
00840183530990BR Surgical, LLCBR99-29333BR99-293332025-09-05
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00840183526986BR Surgical, LLCBR900-7110BR900-71102024-07-23

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