FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040045244
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1004186
Catalog number
1004186
Device description
Scaler Sickle SE 23
Published
2020-01-03
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
00304040045244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040045244003040400452443040400452440304040045244

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
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB5010TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5020TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5030TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5040TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5110TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5150TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5190TBS BASICSACME ENTERPRISE.EMN2026-05-20
EZPF2423804S0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2026-04-13
EZPF2423804SD0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2026-04-13
EZPF2423806HF0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2026-04-13
EZPF2423823A0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2026-04-13
08800075614841OSUNG MNDOSUNG MND Co., Ltd.EMN2025-11-03
07898506810871QuinelatoSchobell Industrial LtdaEMN2023-01-09
07898506810888QuinelatoSchobell Industrial LtdaEMN2023-01-09
EZPFKS242880HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2022-12-16
08800000981444Metal ScalerOsstem Implant Co., Ltd.EMN2022-12-08
08800000981451Metal ScalerOsstem Implant Co., Ltd.EMN2022-12-08
08800000981468Metal ScalerOsstem Implant Co., Ltd.EMN2022-12-08
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ESAM12787001STOMA®Storz am Mark GmbHEMN2020-08-27
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ESAM12835101STOMA®Storz am Mark GmbHEMN2020-08-27
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ESAM12893101STOMA®Storz am Mark GmbHEMN2020-08-27