FDA.reportPublic FDA data

BEAR

Primary DI
G043707640
Brand
BEAR
Company
Bear-Ent, LLC
Model
7.07.64
Catalog number
7.07.64
Device description
Sinus Curette, Oval Cup, Straight Shaft
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
G043707640PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
123551586
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
G043111500BEAR1.11.501.11.502026-07-08
G043111510BEAR1.11.511.11.512026-07-08
G043111520BEAR1.11.521.11.522026-07-08
G043111540BEAR1.11.541.11.542026-07-08
G043111550BEAR1.11.551.11.552026-07-08
G043111560BEAR1.11.561.11.562026-07-08
G043111570BEAR1.11.571.11.572026-07-08
G043111580BEAR1.11.581.11.582026-07-08
G043111590BEAR1.11.591.11.592026-07-08
G043111600BEAR1.11.601.11.602026-07-08
G04320061G0GEIZ2.00.61.G2.00.61.G2026-05-26
G04320062G0GEIZ2.00.62.G2.00.62.G2026-05-26
G04320065G0GEIZ2.00.65.G2.00.65.G2026-05-26
G04320067G0GEIZ2.00.67.G2.00.67.G2026-05-26
G04320068G0GEIZ2.00.68.G2.00.68.G2026-05-26
G043200600BEAR2.00.602.00.602022-08-03
G043200610BEAR2.00.612.00.612022-08-03
G043200620BEAR2.00.622.00.622022-08-03
G043200630BEAR2.00.632.00.632022-08-03
G043200640BEAR2.00.642.00.642022-08-03

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Primary DI, Brand, Company table
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09348811100368INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-28
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09348811100979INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-25
00757770668410Bausch + LombBausch & Lomb IncorporatedKAP2025-08-05
00757770684618Bausch + LombBausch & Lomb IncorporatedKAP2025-08-05
00757770422944Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770424764Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770425716Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770431182Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770434046Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770434640Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770403004Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770406562Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770410859Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770411962Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770418589Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770419845Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770420506Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770422630Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770402779Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770403776Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770404483Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770406586Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770420360Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770423088Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00887482116203Symmetry PaparellaASPEN SURGICAL PRODUCTS, INC.KAP2024-09-05
00887482119358Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KAP2024-09-05
00194613068608MSI Precision Specialty InstrumentsMed Saver, Inc.KAP2024-08-15
00840183527327BR Surgical, LLCBR Surgical, LLCKAP2024-07-16
00840183522537BR Surgical, LLCBR Surgical, LLCKAP2024-06-03