FDA.reportPublic FDA data

MARK3

Primary DI
D7962400CS1
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
2400CS
Device description
High Volume Evacuation (HVE) Tips 1 Vent 10/cs. - MARK3
Published
2021-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EHZEvacuator, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7962400CS1PrimaryHIBCC0
D7962400Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction systemAn assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry place.

Regulatory Flags#

DUNS number
096191093
Device count
1000
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014374983MARK3®597259722026-02-05
00850014374990MARK3®597459742026-02-05
00850014374648MARK3863-014C863-014C2025-10-16
00850014374655MARK3837-018XC837-018XC2025-10-16
D79690931MARK3909390932022-03-25
D79690901MARK390902017-04-14
D79690911MARK390912017-04-14
D79690921MARK390922017-04-14
D79641251MARK3412541252022-05-27
D79641261MARK3412641262022-05-27
D79653701MARK3537053702022-05-19
D79690031MARK390032025-03-06
D7969003MARK390032025-03-06
D79690011MARK390012025-02-28
D7969001MARK390012025-02-28
D7966125CS1MARK36125CS2021-04-22
D7966127CS1MARK36127CS2021-04-22
D7966129CS1MARK36129CS2021-04-23
D79661270MARK361272021-04-23
D79661290MARK361292021-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00723896029848Practicon Color Splash™ Saliva Ejectors 100/PackPRACTICON, INC.EHZ2026-01-08
10371347017790Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017806Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017813Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017820Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347018448Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-03-04
TQ26ST2553121Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553211Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553311Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553411Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553521Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553621Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553721Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553921Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
10080196553686MEDLINEMEDLINE INDUSTRIES, INC.EHZ2024-09-19
10889950144838Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144845Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144852Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144869Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144876Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144883Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10888277652941MedlineMEDLINE INDUSTRIES, INC.EHZ2024-01-24
D248B101051Saliva Ejector Tip (Gray) - Pack of 10HAGER WORLDWIDE, INC.EHZ2023-09-12
D248B101081Saliva Ejector Tip (Gray) - Pack of 3HAGER WORLDWIDE, INC.EHZ2023-09-12
D248B101120Serviceable Saliva EjectorHAGER WORLDWIDE, INC.EHZ2023-09-12
10889950140717HuFriedyGroupHU-FRIEDY MFG. CO., LLCEHZ2023-05-26
10889950140724HuFriedyGroupHU-FRIEDY MFG. CO., LLCEHZ2023-05-26
H668D6401141PearsonKeystone IndustriesEHZ2023-02-20
H668D6401151PearsonKeystone IndustriesEHZ2023-02-20
H668D6401211PearsonKeystone IndustriesEHZ2023-02-20