Roticulator 55 Poly

GUDID 20884521047614

Stapler with Polysorb Staples

Covidien LP

Open-surgery manual linear cutting stapler, single-use
Primary Device ID20884521047614
NIH Device Record Key994d1512-f4d6-4aef-b513-46fd377a7040
Commercial Distribution Discontinuation2020-09-03
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRoticulator 55 Poly
Version Model Number013601
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
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

Height0.2 Inch
Length55 Millimeter
Height0.2 Inch
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Operating and Storage Conditions

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
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
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
GS110884521047617 [Primary]
GS120884521047614 [Package]
Contains: 10884521047617
Package: CASE [3 Units]
Discontinued: 2020-09-03
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GDWSTAPLE, IMPLANTABLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-11-26
Device Publish Date2015-08-28

On-Brand Devices [Roticulator 55 Poly]

20884521047645Stapler with Polysorb Staples
20884521047614Stapler with Polysorb Staples

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