FDA.reportPublic FDA data

BEAR

Primary DI
G043104110
Brand
BEAR
Company
Bear-Ent, LLC
Model
1.04.11
Catalog number
1.04.11
Device description
Curved Sinus Suction, Frazier Handle, 8 Fr, Short
Published
2022-03-02
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
KAMCannula, Sinus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAMCannula, SinusGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043104110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B390197230FLA1Reprocessed 4mm EndoScrub Sheath, 45 deg, K StorzSURETEK MEDICALKAM2026-04-30
09348811099082INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099099INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099112INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099129INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
04250381847145Cannula for Krause ear polyps snareSpiggle & Theis Medizintechnik GmbHKAM2025-10-10
04250676721075Eicken antrum cannulaSpiggle & Theis Medizintechnik GmbHKAM2025-10-05
04250676745132Cannula RegensburgSpiggle & Theis Medizintechnik GmbHKAM2025-10-05
04250676740618Laryngeal cannulaSpiggle & Theis Medizintechnik GmbHKAM2025-09-12
00757770420797Bausch + LombBausch & Lomb IncorporatedKAM2025-08-15
00757770683505Bausch + LombBausch & Lomb IncorporatedKAM2025-08-05
00194613023133MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613102364MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613102388MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613107444MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613107451MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613108571MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
B3901912038T1Reprocessed 4mm EndoScrub 2 Sheath, 0 deg, w/TubingSURETEK MEDICALKAM2025-05-01
B390197230CVA1Reprocessed 4mm EndoScrub Sheath, 70 deg, K StorzSURETEK MEDICALKAM2025-04-25
00194613065379MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613102371MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613102746MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613108502MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
10080196392278MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
10888277371774MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
20080196392275MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
20888277371771MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
04250676742360Suction tubeSpiggle & Theis Medizintechnik GmbHKAM2024-12-27
08904461006835OSSEOUS Suction Tube for Sinus-DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-07-03
08904461006842OSSEOUS Suction Tube for Sinus-DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-07-03