FDA.reportPublic FDA data

Suction Cannula

Primary DI
10840199535009
Brand
Suction Cannula
Company
KOROS U.S.A., INC.
Model
8200-42
Catalog number
8200-42
Device description
"Suction Cannula Small Tip 4.2mm, 24cm 9-1/2"""
Published
2022-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00840199535002Direct MarkingGS10
10840199535009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199535002008401995350028401995350020840199535002
1084019953500910840199535009

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags#

DUNS number
007928633
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840199515995Fiberoptic Dual End Cable7332-607332-602024-12-31
10840199516008Fiberoptic Light Port7332-627332-622024-12-31
10840199516015Fiberoptic Light Port7332-647332-642024-12-31
10840199531056Impactor7585-027585-022022-03-01
10840199531186Impactor7585-447585-442022-03-01
10840199528834Comfort Plus Chisel7540-067540-062025-01-31
00840199528837Comfort Plus Chisel7540-067540-062025-01-31
10840199500007Dilator Tube Set, Single Use, Sterile 7332-99D7332-99D2022-01-31
10840199507723Separator7230-107230-102024-12-31
10840199507730Separator7230-157230-152024-12-31
10840199507747Elevator7230-187230-182024-12-31
10840199507754Elevator7230-207230-202024-12-31
10840199507761Elevator7230-257230-252024-12-31
10840199507778Elevator7230-307230-302024-12-31
10840199507785Elevator7230-357230-352024-12-31
10840199507792Elevator7230-407230-402024-12-31
10840199507808Elevator7230-427230-422024-12-31
10840199507815Elevator7230-437230-432024-12-31
10840199507877Elevator7230-607230-602024-12-31
10840199507907Hook7232-057232-052024-12-31

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