Guided Surgery 260-920-311

GUDID 00813110028082

2.0 x 11.0mm Guided Pilot Drill

BICON, LLC

Fixture/appliance dental drill bit, reusable
Primary Device ID00813110028082
NIH Device Record Keybb49bd5a-1477-4b18-8e73-86c88aca8186
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuided Surgery
Version Model Number260-920-311
Catalog Number260-920-311
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813110028082 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813110028082]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-25
Device Publish Date2019-05-20

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