SILS Port SILSPT15

GUDID 20884523002659

Flexible Port

Covidien LP

TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical TEM/TEO rectoscope, optical
Primary Device ID20884523002659
NIH Device Record Key244b5efa-7953-4071-9604-6e88b920a0f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSILS Port
Version Model NumberSILSPT15
Catalog NumberSILSPT15
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

Device Dimensions

Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter
Outer Diameter5 Millimeter
Outer Diameter15 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *;
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
GS110884523002652 [Primary]
GS120884523002659 [Package]
Contains: 10884523002652
Package: CASE [6 Units]
In Commercial Distribution

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 Number4
Public Version Date2019-06-19
Device Publish Date2016-09-24

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