FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040128411
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1026508
Catalog number
1026508
Device description
Art Excavator #2
Published
2020-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKCEXCAVATOR, DENTAL, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040128411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040128411003040401284113040401284110304040128411

GMDN Terms#

Term, Definition table
TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. 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
07898506841585QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843282QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843299QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843305QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843763QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843770QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843787QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506851799QuinelatoSchobell Industrial LtdaEKC2022-12-08
10889950010065HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010072HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010089HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010096HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010102HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010119HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010126HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010133HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010140HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010157HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010164HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010171HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010188HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010195HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010201HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010218HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010225HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010232HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010249HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010256HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010263HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010270HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12