FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919683902
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5023604U0
Catalog number
5023604U0
Device description
EX11/12L6 ODU11/12 LNG #6HDL 1P
Published
2026-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EKBEXPLORER, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKBExplorer, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919683902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919683902008879196839028879196839020887919683902

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical probe, reusableA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. 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
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08404535029703Brasseler USA Sterile Diamond005034SP005034SP2026-05-27
08404535029734Brasseler USA Sterile Diamond005043SP005043SP2026-05-27
08404535029765Brasseler USA Sterile Diamond005046SP005046SP2026-05-27
08404535029796Brasseler USA Sterile Diamond005056SP005056SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017902470FriendoDXM CO., LTDEKB2026-07-13
08800017902487Gutta EasyDXM CO., LTDEKB2026-07-13
08800017902494Gutta EasyDXM CO., LTDEKB2026-07-13
00850083275686Intrace USAPILOTIS TECH LLCEKB2026-07-03
G149TBSB2010TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2020TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2030TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2040TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2050TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3010TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3020TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3030TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3040TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3050TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3060TBS BASICSACME ENTERPRISE.EKB2026-05-16
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10889950010829HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010836HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010843HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010850HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010867HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
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