FDA.reportPublic FDA data

Dukal

Primary DI
20665973028136
Brand
Dukal
Company
Dukal LLC
Model
27201
Catalog number
27201
Device description
Surgical Aspirator Tips, 1/16" Blue NS
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

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
20665973028136PackageGS150In Commercial Distribution
10665973028139PrimaryGS10
00665973028132Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2066597302813620665973028136
1066597302813910665973028139
00665973028132006659730281326659730281320665973028132

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system irrigation handpiece tipA rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. This is a single use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
791014871
Device count
25
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20665973032638Dukal550055002026-01-12
20665973032645Dukal550155012026-01-12
30665973032659Dukal550255022026-01-12
30665973032666Dukal550355032026-01-12
20665973033024Dukal553055302026-02-26
20665973020918Dukal11130111302026-01-30
20665973020932Dukal11127111272026-01-30
30665973032611Dukal986098602025-10-31
30665973032628Dukal986198612025-10-31
30665973032598DukalK-10040K-100402025-09-18
30665973032451UnipackUPP-1015UPP-10152025-06-01
30665973032475UnipackUPP-223UPP-2232025-06-01
30665973032482UnipackUPP-225UPP-2252025-06-01
30665973032499UnipackUPP-29UPP-292025-06-01
30665973032505UnipackUPP-3212UPP-32122025-06-01
30665973032512UnipackUPP-3565UPP-35652025-06-01
30665973032529UnipackUPP-4212UPP-42122025-06-01
30665973032536UnipackUPP-5211UPP-52112025-06-01
30665973032543UnipackUPP-5275UPP-52752025-06-01
30665973032550UnipackUPP-7513UPP-75132025-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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