FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040058862
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1025480
Catalog number
1025480
Device description
Irrigating Needles Side Vent
Published
2020-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DZMNEEDLE, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040058869PrimaryGS10
00304040058862Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404005886910304040058869
00304040058862003040400588623040400588620304040058862

GMDN Terms#

Term, Definition table
TermDefinition
Root canal irrigation blunt needleA slender, hollow, tubular, metal instrument with a blunt tip designed specifically for irrigation of the root canal of a tooth during an endodontic procedure. Sometimes referred to as a root canal irrigation cannula, it is typically attached to a dental syringe (not included) filled with a root canal cleaning solution. It might be bent or straight and might have either a side vented tip or a blunt open-ended tip. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
100
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126508218Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCDZM2026-03-11
00810126508225Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCDZM2026-03-11
50192253037430MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037454MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037461MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037478MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037492MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037515MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037522MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037539MonojectCardinal Health 200, LLCDZM2026-02-10
00840456213629JMUJMU DENTAL, INCDZM2025-12-22
00840456213636JMUJMU DENTAL, INCDZM2025-12-22
00840456213643JMUJMU DENTAL, INCDZM2025-12-22
00840456213650JMUJMU DENTAL, INCDZM2025-12-22
00841336101029Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCDZM2025-11-11
00842517112360Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112384Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112421Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112476Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112483Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
08800123817903V-JectVERICOM CO., LTD.DZM2025-06-25
08800123817941V-JectVERICOM CO., LTD.DZM2025-06-25
08800123817965V-JectVERICOM CO., LTD.DZM2025-06-25
06936018502202baixinAnhui Kangda Medical Products Co.,Ltd.DZM2025-05-28
06936018502257baixinAnhui Kangda Medical Products Co.,Ltd.DZM2025-05-28
G001HSB1071100House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.DZM2024-09-06
86974456210057CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
86974456210217CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
86974456210224CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
G001HSB1071102House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.DZM2024-06-05