Premium Poly CS

GUDID 20884521047669

C-Section Stapler with Polysorb Staples

Covidien LP

Open-surgery manual linear cutting stapler, single-use
Primary Device ID20884521047669
NIH Device Record Key028e177d-155c-4595-af78-7f7149badcae
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium Poly CS
Version Model Number015170
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

Device Dimensions

Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch
Length57 Millimeter
Height0.17 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521047662 [Primary]
GS120884521047669 [Package]
Contains: 10884521047662
Package: CASE [3 Units]
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 Date2021-01-14
Device Publish Date2015-10-12

Devices Manufactured by Covidien LP

20884521084992 - DAR2025-04-21 Catheter Mount
20884521842530 - DAR2025-04-21 Catheter Mount Extension Tube
20884521844770 - DAR2025-04-21 Catheter Mount Extendable Extension Tube
30884522019747 - DAR2025-04-21 Catheter Mount
30884522019754 - DAR2025-04-21 Catheter Mount
30884522019778 - DAR2025-04-21 Catheter Mount
30884522019785 - DAR2025-04-21 Catheter Mount
20884522019801 - DAR2025-04-21 Catheter Mount

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.