STANDARD BURS

GUDID 00887919339366

04-D0139

Peter Brasseler Holdings, LLC

Orthopaedic bur, single-use
Primary Device ID00887919339366
NIH Device Record Key9531fddc-f5b7-40a4-a7a2-2fdf5bff1778
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTANDARD BURS
Version Model Number04-D0139
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
GS100887919339366 [Primary]

FDA Product Code

GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


[00887919339366]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-28
Device Publish Date2025-03-20

On-Brand Devices [STANDARD BURS]

0088791937164916-S0903
0088791937144116-S0109
0088791937012314-C0110
0088791937011614-C0109
0088791937010914-C0108
0088791936041412-C0905
0088791936038412-C0170
0088791936037712-C0109
0088791934085010-C0617
0088791934081210-C0107
0088791934017109-S0115
0088791933981609-C0901
0088791933973107-S1605
0088791933932804-C0617
0088791933929804-C0609
0088791933926704-C0604
0088791933916804-C0110
0088791933915104-C0109
0088791933914404-C0108
0088791933742303-C0901
0088791936036012-C0108
0088791933988509-D0135
0088791933979309-C0170
0088791933936604-D0139
0088791933922904-C0310
0088791933918204-C0302
0088791933917504-C0170
0088791933913704-C0107
0088791933743003-C0905

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.