FDA.reportPublic FDA data

BEAR

Primary DI
G043661010
Brand
BEAR
Company
Bear-Ent, LLC
Model
6.61.01
Catalog number
6.61.01
Device description
Farrel Applicator, Triangular Tip, 14cm
Published
2022-05-03
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
KCJApplicator, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCJApplicator, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043661010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, reusableA hand-held manual device in the form of a slender handle made of metal intended to hold an absorbent material such as a cotton pledget at its distal end for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is typically used in a healthcare setting. 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
00757770410972Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420179Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420766Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770427383Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00850027492698NavägeRhinosystems, Inc.KCJ2024-11-15
00887482037898Symmetry FarrellASPEN SURGICAL PRODUCTS, INC.KCJ2024-08-15
00840183517489BR Surgical, LLCBR Surgical, LLCKCJ2024-05-29
04055207009734NARichard Wolf GmbHKCJ2024-05-21
00850022483073Saline Noze MistDr. Noze Best, LLCKCJ2024-02-05
G586E1032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E1035960Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032250Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032270Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032290Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032770Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032790Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91035460Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91035960Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
00842331192524Novo Surgical Inc. NOVO SURGICAL, INC.KCJ2023-12-07
05060259070426Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070488Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070853DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070983DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070990DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259073120DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259073137DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
25060259070420Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
45060259070486Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
25060259070857DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05