FDA.report

MARK3

Primary DI
D7962400
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
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EHZEvacuator, Oral Cavity

Product Code Classifications

CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D79624000PrimaryHIBCC0
D7962400CS1PrimaryHIBCC0
D7962400Unit of UseHIBCC0

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry place.

Sterilization Methods

Method

Regulatory Flags

DUNS number
096191093
Device count
1000
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850014374983MARK3®597259722026-02-05
00850014374990MARK3®597459742026-02-05
D7969003MARK390032025-03-06
D7969001MARK390012025-02-28
00850014374532MARK3855-016XC855-016XC2024-07-24
00850014374549MARK3848-018XC848-018XC2024-07-24
00850014374556MARK3652S-018XC652S-018XC2024-07-24
00850014374563MARK3655S-018XC655S-018XC2024-07-24
00850014374570MARK3855-018C855-018C2024-07-24
00850014374587MARK3652S-017XC652S-017XC2024-07-24
D79616501MARK3165016502024-07-22
D79616521MARK3165216522024-07-22
D79616541MARK3165416542024-07-22
D79614260MARK3142614262023-11-15
D7961426X0MARK31426X1426X2023-11-15
D79614300MARK3143014302023-11-15
D79614320MARK3143214322023-11-15
D79614330MARK3143314332023-11-15
D79619112MARK3191119112023-11-09
D79619122MARK3191219122023-11-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810126505675Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEHZ2026-03-05
00849296017800WelmedWELMED INC.EHZ2026-02-15
00849296017817WelmedWELMED INC.EHZ2026-02-15
00723896029855Practicon Color Splash™ Saliva Ejectors 100/PackPRACTICON, INC.EHZ2026-01-08
00841336128811Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-20
00371347017793Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347017809Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347017816Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347017823Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00841336105553Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336105560Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336105577Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336108509Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336108578Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336109995Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336110489Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336111639Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00842517104747Karl SchumacherKarl Schumacher Dental, LLCEHZ2025-07-08
00860349001720SWIK Modular MouthpieceSaliva Management Systems, Inc.EHZ2025-06-17
00860349001737SWIK Modular Extension TubingSaliva Management Systems, Inc.EHZ2025-06-17
00842517104129Karl SchumacherKarl Schumacher Dental, LLCEHZ2025-04-23
10371347018445Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-03-04
00814005020006TAQuality Aspirators, Inc.EHZ2025-02-27
0081400502001315P2-90AQuality Aspirators, Inc.EHZ2025-02-27
0081400502003703BATQuality Aspirators, Inc.EHZ2025-02-27
0081400502005115P3AQuality Aspirators, Inc.EHZ2025-02-27
0081400502006803BAQuality Aspirators, Inc.EHZ2025-02-27
0081400502008202BAQuality Aspirators, Inc.EHZ2025-02-27
0081400502009946P3MQuality Aspirators, Inc.EHZ2025-02-27
0081400502010515P2ATQuality Aspirators, Inc.EHZ2025-02-27