BrioPrep Sterile Diamonds 5031862U0

GUDID 08404535021943

BRIO859EF.31.014 (EF) NDLE 25P

Peter Brasseler Holdings, LLC

Diamond dental bur, single-use
Primary Device ID08404535021943
NIH Device Record Key25d23e4a-4e9c-4d02-898a-6baba31efeb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrioPrep Sterile Diamonds
Version Model Number5031862U0
Catalog Number5031862U0
Company DUNS082080136
Company NamePeter Brasseler Holdings, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108404535021943 [Primary]

FDA Product Code

DZPINSTRUMENT, DIAMOND, DENTAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-03-06
Device Publish Date2025-11-21

On-Brand Devices [BrioPrep Sterile Diamonds]

08404535022186BRIO6368.31.020 (C) FTBALL 25P
08404535022155BRIO5856.31.023 (SC) RD TAP 25P
08404535022124BRIO8368.31.020 (F) FTBALL 25P
08404535022001BRIO6830.31.012 (C) PEAR 25P
08404535021974BRIO6859.31.014 (C) NEEDLE 25P
08404535021943BRIO859EF.31.014 (EF) NDLE 25P
08404535021912BRIO6837.31.012 (C) FLT CYLN 25P
08404535021882BRIO368EF.31.023 (EF) FTBLL 25P
08404535021851BRIO830L.31.012 (M) PEAR 25P
08404535021820BRIO8379.31.025 (F) FTBALL 25P
08404535021790BRIO6909.31.040 (C) WHEEL 25P
08404535021769BRIO8859.31.014 (F) NEEDLE 25P

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