FDA.reportPublic FDA data

High Volume Evacuator Tips

Primary DI
50732224000577
Brand
High Volume Evacuator Tips
Company
CROSSTEX INTERNATIONAL, INC.
Model
ZES50
Device description
High Volume Evacuator Tips, Slotted White
Published
2022-09-29
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYNMouthpiece, saliva ejector
EHZEvacuator, oral cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30732224000573PackageGS120In Commercial Distribution
50732224000577PackageGS14In Commercial Distribution
10732224000579PrimaryGS10
00732224000572Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3073222400057330732224000573
5073222400057750732224000577
1073222400057910732224000579
00732224000572007322240005727322240005720732224000572

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, single-useA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(585)359-0167regulatoryaffairs@hu-friedy.com

Regulatory Flags#

DUNS number
057728685
Device count
50
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10732224000050Crosstex InternationalSCMSCM2016-11-11
30732224120233Isofluid Surgical MasksGCIPWBGCIPWB2016-11-11
50732224005008Safe-Flo Plus Saliva EjectorM1002WHWHM1002WHWH2024-11-22
50732224004988Safe-Flo Plus Saliva EjectorM1003CLWHM1003CLWH2024-11-22
50732224005015Safe-Flo Plus Saliva EjectorM1004WHGRM1004WHGR2024-11-22
50732224005022Safe-Flo Plus Saliva EjectorM1005WHPKM1005WHPK2024-11-22
00732224005508DentaPure 365-Day Independent Water Bottle Cartridge*DP365B102022-11-21
00732224005515DentaPure Water Purification Municipal Cartridge*DP365M102022-11-21
00732224005522DentaPure Water Purification Bottle Cartridge*DP40B102022-11-21
00732224005690CrosstexZFFAD-100ZFFAD-1002024-04-19
00732224721484Sporview 10 Hour Self Contained BISVT-504SVT-5042024-04-10
20815878025321Burkhart Non-Woven SpongesENCNWLBK2024-04-09
20815878027585Burkhart Non-Woven SpongesENC100BK2024-04-09
20815878027592Burkhart Cotton RollsDNACBK2024-04-09
20815878028483Burkhart Non-Woven SpongesENC4NWLBK2024-04-09
10732224005673DentaPure Water Purification Bottle CartridgeDPI365B2024-04-08
10732224005680DentaPure Water Purification Municipal CartridgeDPI365M2024-04-08
00732224005676DentaPure Water Purification Bottle CartridgeDPI365B102024-04-08
00732224005683DentaPure Water Purification Municipal CartridgeDPI365M102024-04-08
10732224001736Articulating PaperTPTH2022-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126505675Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEHZ2026-03-05
00840161311733Lingua-Fix® - Low-Volume Evacuator - 1 Count Sample PackZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00840161311764SE Cushion - Saliva Ejector Cushion - 5 Count Sample PackZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00840161311788Pink Petal™ - Saliva Ejector Holder - 3 Count Sample PackZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00840161311801Mr. Thirsty® One-Step - High Volume Evacuator - Variety 3 Count Sample PZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00849296017800WelmedWELMED INC.EHZ2026-02-15
00849296017817WelmedWELMED INC.EHZ2026-02-15
00723896029855Practicon Color Splash™ Saliva Ejectors 100/PackPRACTICON, INC.EHZ2026-01-08
07615208584981Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208584998Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208543506Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
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
D9099002011ORTHO ARCHOrtho Arch Company IncDYN2025-09-15
00842517104747Karl SchumacherKarl Schumacher Dental, LLCEHZ2025-07-08
00840456209158JMUJMU DENTAL, INCDYN2025-06-17
00860349001720SWIK Modular MouthpieceSaliva Management Systems, Inc.DYN2025-06-17
00860349001720SWIK Modular MouthpieceSaliva Management Systems, Inc.EHZ2025-06-17
00860349001737SWIK Modular Extension TubingSaliva Management Systems, Inc.EHZ2025-06-17