DFS 070614

GUDID 20884521080741

Fascia Stapler

Covidien LP

Open-surgery manual linear stapler, single-use
Primary Device ID20884521080741
NIH Device Record Key70147d08-d837-45e9-a90c-b85767a8d221
Commercial Distribution StatusIn Commercial Distribution
Brand NameDFS
Version Model Number070614
Catalog Number070614
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

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *;

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521080744 [Primary]
GS120884521080741 [Package]
Contains: 10884521080744
Package: CASE [6 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 Date2019-05-27
Device Publish Date2015-08-28

Devices Manufactured by Covidien LP

20884521038964 - Valleylab2025-04-04 Valleylab Suction Coagulator 10FR/CH (3.33mm), 6" (15.24 cm) Non-Sterile Bulk
20884521033129 - Valleylab2025-03-24 Laparoscopic Handset Four-Function Non-Sterile Bulk;Caution: For manufacturing, processing, or repacking
30884522020279 - DAR2025-03-18 Catheter Mount
10884522034753 - DAR2025-03-18 Catheter Mount Extendable
10884522034791 - DAR2025-03-18 Catheter Mount Extendable
20884521066172 - DAR2025-03-17 Catheter Mount Extendable
10884521528086 - DAR2025-03-17 Catheter Mount
20884522020081 - DAR2025-03-17 Catheter Mount

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