BioTritis 2110SS

GUDID 10884521513334

Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 8 mm Fixation Washer and Trocar Tip Drill/Drill Guide

Covidien LP

Meniscus screw
Primary Device ID10884521513334
NIH Device Record Key73b5234f-81b2-4b05-b7d6-c9c1b9cccb3c
Commercial Distribution Discontinuation2018-02-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBioTritis
Version Model Number2110SS
Catalog Number2110SS
Company DUNS058614483
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter
Width8 Millimeter
Length30 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *;

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521513334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-04-01
Device Publish Date2016-09-24

On-Brand Devices [BioTritis]

10884521513532Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 10 mm Fixation Washer an
10884521513495Bio Absorbable ACL Tibial Fixation System
10884521513471Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 10 mm Fixation Washer an
10884521513457Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 8 mm Fixation Washer and
10884521513358Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 8 mm Fixation Washer and
10884521513341Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 8 mm Fixation Washer and
10884521513334Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 8 mm Fixation Washer and

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