Telescoping Burs

GUDID 08404535013658

BR5820-2C-050

Peter Brasseler Holdings, LLC

Orthopaedic bur, single-use
Primary Device ID08404535013658
NIH Device Record Key4c4cf298-2d69-44b0-b09b-2ee4df0dc4dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTelescoping Burs
Version Model NumberBR5820-2C-050
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
GS108404535013658 [Primary]

FDA Product Code

GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


[08404535013658]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-12
Device Publish Date2025-03-04

On-Brand Devices [Telescoping Burs]

08404535013689BR5820-2C-060
08404535013658BR5820-2C-050
08404535013597BR5820-2C-030
08404535013566BR5820-2C-020

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