Endo Universal 65 173054

GUDID 20884521070537

Universal Hernia Stapler

Covidien LP

Surgical staple loading unit, non-cutting
Primary Device ID20884521070537
NIH Device Record Keya776ca6a-6fd5-407e-99d0-ca564ed2345a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo Universal 65
Version Model Number173054
Catalog Number173054
Company DUNS058614483
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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
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

Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter
Height4 Millimeter
Outer Diameter12 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *;
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521070530 [Primary]
GS120884521070537 [Package]
Contains: 10884521070530
Package: CASE [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-05-07
Device Publish Date2016-09-24

On-Brand Devices [Endo Universal 65]

20884521070537Universal Hernia Stapler
20884521070520Universal Hernia Stapler
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