Trephine 260-801-810

GUDID 00813110025821

10mm Trephine

BICON, LLC

Steel dental bur
Primary Device ID00813110025821
NIH Device Record Key1a084fd1-c9d4-4b48-835f-b63f9259193d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrephine
Version Model Number260-801-810
Catalog Number260-801-810
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 Batchtrue
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
GS100813110025821 [Primary]

FDA Product Code

EJLBur, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813110025821]

Moist Heat or Steam Sterilization


[00813110025821]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-25
Device Publish Date2016-05-06

On-Brand Devices [Trephine]

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008131100258696.0mm Trephine
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008131100258454.25mm Trephine
008131100258383.75mm Trephine (4.6mm OD)
0081311002582110mm Trephine

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