Guided Surgery 260-920-005

GUDID 00813110028044

2.0mm Guided Surgery Rings

BICON, LLC

Surgical drill guide, reusable
Primary Device ID00813110028044
NIH Device Record Key6fea3148-314a-48ab-8333-911235900f50
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuided Surgery
Version Model Number260-920-005
Catalog Number260-920-005
Company DUNS945015758
Company NameBICON, LLC
Device Count5
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
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100813110028044 [Primary]
GS110813110028041 [Unit of Use]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813110028044]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-25
Device Publish Date2019-02-06

On-Brand Devices [Guided Surgery]

008131100265145.0mm Guided Surgery Rings
008131100264154.5mm Guided Surgery Rings
008131100263094.0mm Guided Surgery Rings
008131100261493.0mm Guided Surgery Rings
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.