FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919771371
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5025828U0
Device description
CP12 MARQUIS X2 SE 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
OTC
false
Sterile
false
Single use
false

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
00887919771371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919771371008879197713718879197713710887919771371

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
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
08404535019247Brasseler USA5031780U05031780U02026-03-24
08404535024906Brasseler USA5032029U05032029U02026-03-23
08404535024937Brasseler USA5032030U05032030U02026-03-23
08404535024968Brasseler USA5032031U05032031U02026-03-23
08404535025156LARGE BONE BLADESBR1-12100-50BR1-12100-502026-03-23
08404535024579Brasseler USAFL17CHP5032016U02026-03-17
08404535024609Brasseler USAFL17MHP5032017U02026-03-17
08404535024630Brasseler USAFL17FHP5032018U02026-03-17
08404535024661Brasseler USAFL17UF5032019U02026-03-17
08404535021769BrioPrep Sterile Diamonds5031856U05031856U02025-11-21
08404535021790BrioPrep Sterile Diamonds5031857U05031857U02025-11-21
08404535021820BrioPrep Sterile Diamonds5031858U05031858U02025-11-21
08404535021851BrioPrep Sterile Diamonds5031859U05031859U02025-11-21
08404535021882BrioPrep Sterile Diamonds5031860U05031860U02025-11-21
08404535021912BrioPrep Sterile Diamonds5031861U05031861U02025-11-21
08404535021943BrioPrep Sterile Diamonds5031862U05031862U02025-11-21
08404535021974BrioPrep Sterile Diamonds5031863U05031863U02025-11-21
08404535022001BrioPrep Sterile Diamonds5031864U05031864U02025-11-21
08404535022124BrioPrep Sterile Diamonds5031880U05031880U02025-11-21
08404535022155BrioPrep Sterile Diamonds5031881U05031881U02025-11-21

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
10860012076601UMarcNew Venture Enterprise Ltd.EMP2024-07-03
20860012076615UMarcNew Venture Enterprise Ltd.EMP2024-07-03
00841336101760Salvin Stainless Steel UNC ProbeSalvin Dental Specialties, Inc.EMP2023-08-21
00841336105430Perio Probe BlackSalvin Dental Specialties, Inc.EMP2023-08-10
00841336101791Salvin Titanium CP12 Perio ProbeSalvin Dental Specialties, Inc.EMP2023-07-31
00841336101807Salvin Titanium UNC-15 Perio ProbeSalvin Dental Specialties, Inc.EMP2023-07-31
10889950086527Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMP2023-04-07
00887919771432Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
00887919771463Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
00887919771494Brasseler USAPeter Brasseler Holdings, LLCEMP2022-12-08
04251436904646KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGEMP2021-08-30
04251436904936KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGEMP2021-08-30
04251436905032KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGEMP2021-08-30
04251436905049KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGEMP2021-08-30
04251436905056KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGEMP2021-08-30
04251436905063KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGEMP2021-08-30
04251436925818KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGEMP2021-08-30
04251436925856KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGEMP2021-08-30
04251436930621KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGEMP2021-08-30
04251436931253KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGEMP2021-08-30
04251436931260KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGEMP2021-08-30
04251436933141KOHDENTKohdent Roland Kohler Medizintechnik GmbH & Co. KGEMP2021-08-30
00840105217442ZOLL-DENTALZoll-DentalEMP2021-03-10
00840105217459ZOLL-DENTALZoll-DentalEMP2021-03-10
H834701540Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEMP2018-02-26
H834701560Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEMP2018-02-26