FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040102807
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701276
Catalog number
5701276
Device description
Maxima Hedstromfile 25mm #15
Published
2019-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EKSFILE, PULP CANAL, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040102807PrimaryGS10
00304040102800Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404010280710304040102807
00304040102800003040401028003040401028000304040102800

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic file/rasp, reusableA hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a reusable device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
012430880
Device count
6
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
true

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
06941877830076EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-05-26
06941877830083EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-05-26
80810213810008EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810015EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810022EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810039EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810046EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810053EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810060EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810077EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810084EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810091EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810107EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810114EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810121EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810138EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810145EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810152EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810169EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810176EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810183EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810190EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810206EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810213EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810220EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810237EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810244EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810251EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810268EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810275EdgeEndoHSG-S Corp.EKS2026-03-23