FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183522537
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR46-61019
Catalog number
BR46-61019
Device description
Sinus Frontal Curette, curved, 55° angle, 2mm x 5mm, 7 1/2"
Published
2024-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00840183522537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183522537008401835225378401835225370840183522537

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

Contacts#

Phone, Email table
PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags#

DUNS number
134781207
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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Primary DI, Brand, Model table
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00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183530983BR Surgical, LLCBR99-29332BR99-293322025-09-05
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00840183530822BR Surgical, LLCBR99-29453BR99-294532025-09-03
00840183530839BR Surgical, LLCBR99-29454BR99-294542025-09-03
00840183530846BR Surgical, LLCBR99-29455BR99-294552025-09-03
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00840183530860BR Surgical, LLCBR99-29457BR99-294572025-09-03
00840183530877BR Surgical, LLCBR99-29458BR99-294582025-09-03

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