ILA 3957

GUDID 10884521064607

Reusable Stapler

Covidien LP

Open-surgery manual linear stapler, reusable Open-surgery manual linear stapler, reusable Open-surgery manual linear stapler, reusable Open-surgery manual linear stapler, reusable Open-surgery manual linear stapler, reusable Open-surgery manual linear stapler, reusable Open-surgery manual linear stapler, reusable Open-surgery manual linear stapler, reusable Open-surgery manual linear stapler, reusable Open-surgery manual linear stapler, reusable Open-surgery manual linear stapler, reusable Open-surgery manual linear stapler, reusable Open-surgery manual linear stapler, reusable
Primary Device ID10884521064607
NIH Device Record Key09afafe0-6727-4874-875e-787497e9b99d
Commercial Distribution Discontinuation2020-09-03
Commercial Distribution StatusNot in Commercial Distribution
Brand NameILA
Version Model Number3957
Catalog Number3957
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
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

Device Dimensions

Length52 Millimeter
Length52 Millimeter
Length52 Millimeter
Length52 Millimeter
Length52 Millimeter
Length52 Millimeter
Length52 Millimeter
Length52 Millimeter
Length52 Millimeter
Length52 Millimeter
Length52 Millimeter
Length52 Millimeter
Length52 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521064607 [Primary]
GS110884521064607 [Primary]
GS110884521064607 [Primary]
GS110884521064607 [Primary]
GS110884521064607 [Primary]
GS110884521064607 [Primary]
GS110884521064607 [Primary]
GS110884521064607 [Primary]
GS110884521064607 [Primary]
GS110884521064607 [Primary]
GS110884521064607 [Primary]
GS110884521064607 [Primary]
GS110884521064607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GDWSTAPLE, IMPLANTABLE
GDWSTAPLE, IMPLANTABLE
GDWSTAPLE, IMPLANTABLE
GDWSTAPLE, IMPLANTABLE
GDWSTAPLE, IMPLANTABLE
GDWSTAPLE, IMPLANTABLE
GDWSTAPLE, IMPLANTABLE
GDWSTAPLE, IMPLANTABLE
GDWSTAPLE, IMPLANTABLE
GDWSTAPLE, IMPLANTABLE
GDWSTAPLE, IMPLANTABLE
GDWSTAPLE, IMPLANTABLE
GDWSTAPLE, IMPLANTABLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-15
Device Publish Date2015-08-28

On-Brand Devices [ILA]

20884521063188Loading Unit
20884521063164Loading Unit
20884521063157Loading Unit
10884521064607Reusable Stapler

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