FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040057015
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1006640
Catalog number
1006640
Device description
Mirror Disposable Dental
Published
2019-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
10304040057015PrimaryGS10
00304040057018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404005701510304040057015
00304040057018003040400570183040400570180304040057018

GMDN Terms#

Term, Definition table
TermDefinition
Dental mirror, single-useA sterile, 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 single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity40 Percent (%) Relative Humidity50 Percent (%) Relative Humidity

Regulatory Flags#

DUNS number
012430880
Device count
72
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040195472Essentials570582857058282026-09-04
10304040195489Essentials570582957058292026-09-04
10304040195038Criterion570581557058152026-07-29
10304040195045Criterion570581657058162026-07-29
10304040195052Criterion570581757058172026-07-29
10304040195069Criterion570581857058182026-07-29
10304040195076Criterion570582057058202026-07-29
10304040195083Criterion570581957058192026-07-29
10304040195090Criterion570582157058212026-07-29
10304040195106Criterion570582257058222026-07-29
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955MM5CSFS1Paul BandittTerlain Enterprises, Inc.EAX2026-09-25
G879MMFS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFSCS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFSCS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPSCS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPSCS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
00840456218341JMUJMU DENTAL, INCEAX2026-07-07
00840456218358JMUJMU DENTAL, INCEAX2026-07-07
00840456218365JMUJMU DENTAL, INCEAX2026-07-07
00840456218372JMUJMU DENTAL, INCEAX2026-07-07
00840456218389JMUJMU DENTAL, INCEAX2026-07-07
00840456218396JMUJMU DENTAL, INCEAX2026-07-07
08961104622579Dental Mouth Mirror MELPEX BEAUTY INSTRUMENTSEAX2026-05-21
08961104622586Dental Mouth MirrorMELPEX BEAUTY INSTRUMENTSEAX2026-05-21
08961104622944Dental Mouth MirrorMELPEX BEAUTY INSTRUMENTSEAX2026-05-21
G149TBSB3110TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3120TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3130TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3140TBS BASICSACME ENTERPRISE.EAX2026-05-16
1081000052669420/20™PARKELL, INC.EAX2025-09-26
M633680501B4JEDMEDJEDMED INSTRUMENT COMPANYEAX2023-02-03
10371347002550Mirror Front Surface Cone Socket #4The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002567Mirror Front Surface Simple Stem #4The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002574Mirror Front Surface Cone Socket #5The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002581Mirror Front Surface Simple Stem #5The Atlanta Dental Supply CompanyEAX2022-11-23
10818207024203Vista RSS Mirror HandleVista DentalEAX2022-09-01
10818207024210Vista RCS Mirror HandleVista DentalEAX2022-09-01