Signia

GUDID 20884521543505

Loading Unit

Covidien LP

Endoscopic manual linear cutting stapler, single-use
Primary Device ID20884521543505
NIH Device Record Key9dd824d6-f1f1-4f42-a1b1-0891a2f04db9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignia
Version Model NumberSIGLU60A
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

Device Dimensions

Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter
Length60 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit
Storage Environment TemperatureBetween 63 Degrees Fahrenheit and 94 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521543508 [Primary]
GS120884521543505 [Package]
Contains: 10884521543508
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 Date2021-12-07
Device Publish Date2017-05-26

On-Brand Devices [Signia]

10884521543829Linear Adapter Short
10884521543805Linear Adapter
10884521543898Sterilization Tray
10884521703704Circular Adapter Reusable Trocar Tip Protector
10884521703698Black Extra Thick Circular Adapter XL Length
10884521703681Circular Adapter Standard Length
20884521543796Power Shell
20884521741888Small Diameter Curved Tip Intelligent Reload Vascular/Thin; For use with 8 mm Cannula or larger
20884521741871Gray Small Diameter Curved Tip Intelligent Reload Vascular; For use with 8 mm Cannula or larger
20884521741840Small Diameter Curved Tip Intelligent Reload Vascular/Thin; For use with 8 mm Cannula or larger
10884521543850Four-Bay Smart Charger
10884521543867Single-Bay Charger
10884521543782Power Handle
10884521543812Linear Adapter XL
10884521797437Power Handle, Refurbished
20884521543505Loading Unit
20884521543499Loading Unit
10884521543874Reusable Insertion Guide
10884521543881Manual Retraction Tool
10884521845497SIGNIA CIRCULAR ADAPTER XL LENGTH FT
10884521845480SIGNIA CIRCULAR ADAPTER STND LENGTH FT

Trademark Results [Signia]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIGNIA
SIGNIA
90981018 not registered Live/Pending
Hilton International Holding LLC
2021-03-18
SIGNIA
SIGNIA
90701068 not registered Live/Pending
Closet World, Inc.
2021-05-10
SIGNIA
SIGNIA
90586775 not registered Live/Pending
Hilton International Holding LLC
2021-03-18
SIGNIA
SIGNIA
90577665 not registered Live/Pending
Hilton International Holding LLC
2021-03-13
SIGNIA
SIGNIA
90380652 not registered Live/Pending
Jeffery Fell
2020-12-14
SIGNIA
SIGNIA
88704276 not registered Live/Pending
Signia Artwork, LLC
2019-11-23
SIGNIA
SIGNIA
88383023 not registered Live/Pending
SIG Technology AG
2019-04-12
SIGNIA
SIGNIA
87743868 not registered Live/Pending
Hilton International Holding LLC
2018-01-04
SIGNIA
SIGNIA
87588391 not registered Dead/Abandoned
EE CAPITAL LIMITED
2017-08-29
SIGNIA
SIGNIA
86450957 5119954 Live/Registered
Covidien LP
2014-11-11
SIGNIA
SIGNIA
86009779 not registered Dead/Abandoned
EE CAPITAL LIMITED
2013-07-14
SIGNIA
SIGNIA
85859446 not registered Dead/Abandoned
Choi, David
2013-02-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.