FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040130599
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1005834
Catalog number
1005834
Device description
Mirror Plane Simple Stem
Published
2020-03-27
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
false

Product Codes#

Code, Name table
CodeName
EAXMIRROR, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040130596PrimaryGS10
00304040130599Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404013059610304040130596
00304040130599003040401305993040401305990304040130599

GMDN Terms#

Term, Definition table
TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012430880
Device count
12
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
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
04251436934155KOHLERKohler Medizintechnik GmbHEAX2026-03-12
00840161311511Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-02-19
00840161311535Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-02-19
00840161311375Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311382Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311399Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311405Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311412Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311429Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311436Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311443Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00810126506726Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAX2025-12-16
008101265067713D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAX2025-12-16
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00190707193270PixSure Perfect™Ortho Organizers, Inc.EAX2025-10-23
00190707149055PixSure Perfect®Ortho Organizers, Inc.EAX2025-10-01
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