Trephine 260-801-880

GUDID 00813110025883

8.0mm Trephine

BICON, LLC

Titanium dental bur Titanium dental bur
Primary Device ID00813110025883
NIH Device Record Keycf9fa31c-5fae-4e07-a0e4-5948de831937
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrephine
Version Model Number260-801-880
Catalog Number260-801-880
Company DUNS945015758
Company NameBICON, 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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone617-524-4443
Emailsupport@bicon.com
Phone617-524-4443
Emailsupport@bicon.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813110025883 [Primary]

FDA Product Code

EJLBur, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813110025883]

Moist Heat or Steam Sterilization


[00813110025883]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-23
Device Publish Date2016-05-06

On-Brand Devices [Trephine]

008131100258838.0mm Trephine
008131100258767.0mm Trephine
008131100258696.0mm Trephine
008131100258525.25mm Trephine
008131100258454.25mm Trephine
008131100258383.75mm Trephine (4.6mm OD)
0081311002582110mm Trephine

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.