ORAL SURGERY BURS

GUDID 00887919370086

14-C0106

Peter Brasseler Holdings, LLC

Orthopaedic bur, single-use
Primary Device ID00887919370086
NIH Device Record Key106a7ecf-fa2e-40f2-83db-e6e2cfc8a65d
Commercial Distribution StatusIn Commercial Distribution
Brand NameORAL SURGERY BURS
Version Model Number14-C0106
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
GS100887919370086 [Primary]

FDA Product Code

GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00887919370086]

Radiation Sterilization


[00887919370086]

Radiation Sterilization


[00887919370086]

Radiation Sterilization


[00887919370086]

Radiation Sterilization


[00887919370086]

Radiation Sterilization


[00887919370086]

Radiation Sterilization


[00887919370086]

Radiation Sterilization


[00887919370086]

Radiation Sterilization


[00887919370086]

Radiation Sterilization


[00887919370086]

Radiation Sterilization


[00887919370086]

Radiation Sterilization


[00887919370086]

Radiation Sterilization


[00887919370086]

Radiation Sterilization


[00887919370086]

Radiation Sterilization


[00887919370086]

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 [ORAL SURGERY BURS]

0088791933933504-C0623
0088791933928104-C0607
0088791933927404-C0606
0088791937169416-S1801
0088791937008614-C0106
0088791933974808-S1802
0088791933931104-C0615
0088791933923604-C0404

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