FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040129661
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1048370
Catalog number
1048370
Device description
MaxiGrip Scaler DE 204S
Published
2020-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMNSCALER, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040129661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040129661003040401296613040401296610304040129661

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental scaler, reusableA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012430880
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040199602Henry Schein570599457059942026-10-01
00304040199619Henry Schein570599557059952026-10-01
00304040199626Henry Schein570599657059962026-10-01
00304040199633Henry Schein570599757059972026-10-01
00304040199640Henry Schein570599857059982026-10-01
00304040199657Henry Schein570599957059992026-10-01
00304040199664Henry Schein570600057060002026-10-01
00304040199671Henry Schein570600157060012026-10-01
00304040199312Henry Schein570597057059702026-09-30
00304040199091Henry Schein570594357059432026-09-29
00304040199107Henry Schein570594657059462026-09-29
00304040199114Henry Schein570594457059442026-09-29
00304040199121Henry Schein570594757059472026-09-29
00304040199138Henry Schein570594557059452026-09-29
00304040199145Henry Schein570594857059482026-09-29
00304040199152Henry Schein570594957059492026-09-29
00304040199169Henry Schein570595157059512026-09-29
00304040199176Henry Schein570595057059502026-09-29
00304040199183Henry Schein570595257059522026-09-29
00304040199190Henry Schein570595357059532026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456224861JMUJMU DENTAL, INCEMN2026-09-30
00840456224878JMUJMU DENTAL, INCEMN2026-09-30
00840456224885JMUJMU DENTAL, INCEMN2026-09-30
00840456224892JMUJMU DENTAL, INCEMN2026-09-30
00840456224908JMUJMU DENTAL, INCEMN2026-09-30
00840456224915JMUJMU DENTAL, INCEMN2026-09-30
G879102177H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102184H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G8791021850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102185H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102186H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102187H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102191H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102196H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102197H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102211H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102212H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102213H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G8791024050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102RM340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
04963931271214NAYDM CORPORATIONEMN2026-07-09
04963931271221NAYDM CORPORATIONEMN2026-07-09
04963931271238NAYDM CORPORATIONEMN2026-07-09
04963931271245NAYDM CORPORATIONEMN2026-07-09
04963931271252NAYDM CORPORATIONEMN2026-07-09
04963931271269NAYDM CORPORATIONEMN2026-07-09
04963931271276NAYDM CORPORATIONEMN2026-07-09
04963931271283NAYDM CORPORATIONEMN2026-07-09
04963931271290NAYDM CORPORATIONEMN2026-07-09
04963931271306NAYDM CORPORATIONEMN2026-07-09