FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919771432
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5025830U0
Device description
TICP12 SE CC PROBE 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
EMPMARKER, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMPMarker, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919771432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919771432008879197714328879197714320887919771432

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
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08404535029826Brasseler USA Sterile Diamond005255SP005255SP2026-05-27
08404535029857Brasseler USA Sterile Diamond005256SP005256SP2026-05-27
08404535029888Brasseler USA Sterile Diamond005372SP005372SP2026-05-27
08404535029918Brasseler USA Sterile Diamond012223SP012223SP2026-05-27
08404535029949Brasseler USA Sterile Diamond013287SP013287SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251436943805KOHLERKohler Medizintechnik GmbHEMP2026-03-12
00841336108622Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMP2025-11-11
00860012076604UMarcNew Venture Enterprise Ltd.EMP2024-07-03
00860012076611UMarcNew Venture Enterprise Ltd.EMP2024-07-03
10860012076601UMarcNew Venture Enterprise Ltd.EMP2024-07-03
20860012076615UMarcNew Venture Enterprise Ltd.EMP2024-07-03
00841336101760Salvin Stainless Steel UNC ProbeSALVIN DENTAL SPECIALTIES, LLCEMP2023-08-21
00841336105430Perio Probe BlackSALVIN DENTAL SPECIALTIES, LLCEMP2023-08-10
00841336101791Salvin Titanium CP12 Perio ProbeSALVIN DENTAL SPECIALTIES, LLCEMP2023-07-31
00841336101807Salvin Titanium UNC-15 Perio ProbeSALVIN DENTAL SPECIALTIES, LLCEMP2023-07-31
10889950086527Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMP2023-04-07
00887919771371Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
00887919771463Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
00887919771494Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
04251436904646KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436904936KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905032KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905049KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905056KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436905063KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436925818KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436925856KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436930621KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436931253KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436931260KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
04251436933141KOHDENTKohler Medizintechnik GmbHEMP2021-08-30
00840105217442ZOLL-DENTALZoll-DentalEMP2021-03-10
00840105217459ZOLL-DENTALZoll-DentalEMP2021-03-10
10381780450283Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEMP2018-02-26
10381780450290Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEMP2018-02-26