Osteotome 260-901-550

GUDID 00813110026040

5.0mm Osteotome

BICON, LLC

Dental osteotome
Primary Device ID00813110026040
NIH Device Record Key3f079cc8-25e2-463b-9df6-bbcca95bc7e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteotome
Version Model Number260-901-550
Catalog Number260-901-550
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
GS100813110026040 [Primary]

FDA Product Code

EMMChisel, Osteotome, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813110026040]

Moist Heat or Steam Sterilization


[00813110026040]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-25
Device Publish Date2016-04-08

On-Brand Devices [Osteotome]

008131100260576.0mm Osteotome
008131100260405.0mm Osteotome
008131100260334.5mm Osteotome
008131100260264.0mm Osteotome
008131100260193.5mm Osteotome
00813110024176Osteotome Kit

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