FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040120675
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1068857
Catalog number
1068857
Device description
Boone Gauge
Published
2020-08-21
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
false

Product Codes#

Code, Name table
CodeName
EILGAUGE, DEPTH, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040120675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040120675003040401206753040401206750304040120675

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance dimension gaugeA dental instrument intended to be used for accurate measurement of the dimensions of an orthodontic appliance (e.g., orthodontic bracket height) especially as it relates to patient oral anatomy during the fitting of the appliance (e.g., determining distance from the incisal edge to an orthodontic bracket locator blade). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
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
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D909800081C1ORTHO ARCHOrtho Arch Company IncEIL2025-09-15
00842092186626PreatPreat CorporationEIL2025-09-05
D9098000341ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980008114ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980013716ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980013918ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980014010ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
00194613114893MSI Precision Specialty InstrumentsMed Saver, Inc.EIL2025-08-01
E8961732150SCHWERTA. Schweickhardt GmbH & Co. KGEIL2025-04-07
EZPF2474408HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIL2025-03-07
00371347018318Advance Dental ProductsThe Atlanta Dental Supply CompanyEIL2025-01-02
00371347018356Advance Dental ProductsThe Atlanta Dental Supply CompanyEIL2025-01-02
00841336121584Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIL2024-12-11
00190730084682Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084811Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084828Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084835Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084842Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084859Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
08800016113303Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016113488Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121612Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121629Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121636Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121643Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121650Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121667Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08