FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919683605
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5023574U0
Device description
EXC14 EXCAV REG #4 HDL 1P
Published
2022-12-08
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
EKCEXCAVATOR, DENTAL, OPERATIVE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919683605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919683605008879196836058879196836050887919683605

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
082080136
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919838074Brasseler USA5027336U05027336U02023-01-25
00887919711650Brasseler USA5024422U05024422U02026-06-19
00887919711681Brasseler USA5024423U05024423U02026-06-19
00887919683902Brasseler USA5023604U05023604U02026-07-13
08404535030761Brasseler USA5032375U05032375U02026-07-13
08404535030792Brasseler USA5032376U05032376U02026-07-13
08404535030822Brasseler USA5032378U05032378U02026-07-13
08404535018981Brasseler USA5031820U05031820U02026-06-26
08404535019018Brasseler USA5031821U05031821U02026-06-26
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27
08404535029611Brasseler USA Sterile Diamond004820SP004820SP2026-05-27
08404535029642Brasseler USA Sterile Diamond004868SP004868SP2026-05-27
08404535029673Brasseler USA Sterile Diamond004959SP004959SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275624Intrace USAPILOTIS TECH LLCEKC2026-07-03
00348783008500Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008517Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008524Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008531Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008548Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008555Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008562Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008579Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008609Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008616Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008623Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008647Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008661Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008685Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008692Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008708Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
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