FDA.reportPublic FDA data

BEAR

Primary DI
G043101130
Brand
BEAR
Company
Bear-Ent, LLC
Model
1.01.13
Catalog number
1.01.13
Device description
Baron Suction Tube, Light Angle, 3 Fr
Published
2022-02-27
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
JZFTube, Ear Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G043101130PrimaryHIBCC0

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
00190776395537MillenniumAvalign Technologies, Inc.JZF2026-07-14
00190776395667MillenniumAvalign Technologies, Inc.JZF2026-07-14
G043111500BEARBear-Ent, LLCJZF2026-07-08
G043111510BEARBear-Ent, LLCJZF2026-07-08
G043111520BEARBear-Ent, LLCJZF2026-07-08
G043111540BEARBear-Ent, LLCJZF2026-07-08
G043111550BEARBear-Ent, LLCJZF2026-07-08
G043111560BEARBear-Ent, LLCJZF2026-07-08
G043111570BEARBear-Ent, LLCJZF2026-07-08
G043111580BEARBear-Ent, LLCJZF2026-07-08
G043111590BEARBear-Ent, LLCJZF2026-07-08
G043111600BEARBear-Ent, LLCJZF2026-07-08
05060212053466Barron Suction Handle (3Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053473Barron Suction Handle (4Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053480Barron Suction Handle (5Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053497Barron Suction Handle (6Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053503Barron Suction Handle (7Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053534Micro Laryngeal Suction Handle 280mm x 2mm OD (6Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053541Micro Laryngeal Suction Handle 330mm x 2mm OD (6Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053558Micro Laryngeal Suction Handle 330mm x 3mm OD (9Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053565Micro Laryngeal Suction Handle, 360mm x 3mm OD (9Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053572Bronchoscopy Suction Handle 450mm x 4mm OD (12Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060212053589Oesophageal Suction Handle 550mm x 4mm OD (12Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060411982482Micro Laryngeal Suction Handle 240mm x 2mm OD (6Fg)DTR MEDICAL LIMITEDJZF2026-06-10
05060411984288Curved Endoscopic Suction Tube, 3mm Bend Radius, 18 swgDTR MEDICAL LIMITEDJZF2026-06-10
05060411984301Curved Endoscopic Suction Tube, 6mm Bend Radius, 18 swgDTR MEDICAL LIMITEDJZF2026-06-10
00348783011388Premier Frazier Suction TubePREMIER DENTAL PRODUCTS COMPANYJZF2026-06-09
00348783011395Premier Frazier Suction TubePREMIER DENTAL PRODUCTS COMPANYJZF2026-06-09
00348783011401Premier Frazier Suction TubePREMIER DENTAL PRODUCTS COMPANYJZF2026-06-09
00348783011418Premier Frazier Suction TubePREMIER DENTAL PRODUCTS COMPANYJZF2026-06-09