Guided Surgery 260-101-850

GUDID 00813110024589

5.0mm Guided Surgical Kit

BICON, LLC

Dental implant system Dental implant system
Primary Device ID00813110024589
NIH Device Record Key872da40b-ead5-4b44-9298-52c879e0b978
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuided Surgery
Version Model Number260-101-850
Catalog Number260-101-850
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
GS100813110024589 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813110024589]

Moist Heat or Steam Sterilization


[00813110024589]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-24
Device Publish Date2016-06-10

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008131100245966.0mm Guided Surgical Kit
008131100245895.0mm Guided Surgical Kit
008131100245724.5mm Guided Surgical Kit
008131100245654.0mm Guided Surgical Kit
008131100245413.5mm Guided Surgical Kit
008131100245343.0mm Guided Surgical Kit
008131100280822.0 x 11.0mm Guided Pilot Drill
008131100280752.0 x 8.0mm Guided Pilot Drill
008131100280682.0 x 6.0mm Guided Pilot Drill
008131100280512.0 x 5.0mm Guided Pilot Drill
008131100282662.0mm Guided Pilot Kit
008131100280442.0mm Guided Surgery Rings

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