VersaSeal Plus 175772P

GUDID 10884521082595

Cannula Seal

Covidien LP

Laparoscopic access cannula seal reducer
Primary Device ID10884521082595
NIH Device Record Keyb65221d6-32df-4dc1-a703-656df4b9cd77
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersaSeal Plus
Version Model Number175772P
Catalog Number175772P
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 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
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
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter
Outer Diameter12 Millimeter
Outer Diameter5 Millimeter

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521082595 [Package]
Contains: 20884521082592
Package: CASE [6 Units]
In Commercial Distribution
GS120884521082592 [Primary]

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-29

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30884521815265 - Shiley2024-07-30 Oral/Nasal Endotracheal Tube, Intermediate Cuff Non DEHP
20884521815275 - Shiley2024-07-30 Oral/Nasal Endotracheal Tube, Intermediate Cuff Non DEHP
20884521815282 - Shiley2024-07-30 Oral/Nasal Endotracheal Tube, Intermediate Cuff Non DEHP
30884521815296 - Shiley2024-07-30 Oral/Nasal Endotracheal Tube, Intermediate Cuff Non DEHP

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