Endo Stitch

GUDID 20884521100012

Suturing Device

Covidien LP

Suturing unit, single-use
Primary Device ID20884521100012
NIH Device Record Keyc879c6a1-b800-4c7d-ab7d-003527174b37
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo Stitch
Version Model Number173027
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
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

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Outer Diameter10 Millimeter
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Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521100015 [Primary]
GS120884521100012 [Package]
Contains: 10884521100015
Package: CASE [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCWEndoscopic tissue approximation device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-05-25
Device Publish Date2016-09-24

On-Brand Devices [Endo Stitch]

20884521100012Suturing Device
20884521100005Suturing Device

Trademark Results [Endo Stitch]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENDO STITCH
ENDO STITCH
74347852 1914149 Live/Registered
COVIDIEN LP
1993-01-11

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