FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040080849
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9000790
Catalog number
9000790
Device description
Multi-Use Dispenser
Published
2019-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040080849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040080849003040400808493040400808490304040080849

GMDN Terms#

Term, Definition table
TermDefinition
Dental restorative material dispenserA manually-powered, pistol-like device intended to dispense a predetermined amount of a dental restorative material (e.g., amalgam, cement, resin) into a patient’s oral cavity, or into a capsule/well prior to mixing. A prefilled dispensing tip, cannula, or syringe is typically attached to the distal end of this device. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00To be stored in dry and fresh place, protected from sunlight

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
Premarket exempt
true
Lot or batch
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
G8791021110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023030DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G879102305TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G879102335TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023580DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023590DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G879102477TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791024320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-23
G8791024330DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-23
G8791024340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-23
G8791023940DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-10
G879102GS10DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS20DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS30DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS60DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H1H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H2H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H3H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G149TBSB4010TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4020TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4030TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4040TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4050TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4060TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4070TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4080TBS BASICSACME ENTERPRISE.EIY2026-05-20