VersaStep

GUDID 10884521080928

Reposable Dilator

Covidien LP

Laparoscopic access cannula dilator
Primary Device ID10884521080928
NIH Device Record Key40aa9e13-5ebc-49bf-a1f3-9b2b5e926113
Commercial Distribution Discontinuation2022-01-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameVersaStep
Version Model NumberVSR100705
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 Usefalse
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

Device Dimensions

Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521080928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-09-19
Device Publish Date2016-09-24

On-Brand Devices [VersaStep]

10884521093614Insufflation Needle
10884521093607Insufflation Needle
10884521084193Radially Expandable Sleeve
10884521084162Short Radially Expandable Sleeve
10884521084155Long Radially Expandable Sleeve
10884521084148Radially Expandable Sleeve
10884521084131Short Radially Expandable Sleeve
10884521084117Radially Expandable Sleeve
10884521082861Dilator and Cannula with Radially Expandable Sleeve
10884521082830Dilator and Cannula with Radially Expandable Sleeve
20884521082806Dilator and Cannula with Radially Expandable Sleeve
10884521081062Sterilization Tray
10884521081055Reposable Sterilization Tray
10884521081031Reposable Insufflation Needle
10884521081000Reusable Dilator
10884521080980Reusable Dilator
10884521080959Reposable Dilator
10884521080935Reposable Dilator
10884521078581Reusable Cannula
10884521078574Reusable Cannula
10884521078550Reusable Cannula
20884521084206Radially Expandable Sleeve
10884521081048Reposable Insufflation Needle
10884521078567Reusable Cannula
10884521080966Reusable Dilator
10884521080928Reposable Dilator
10884521078598Reusable Cannula
10884521081024Reusable Dilator
10884521081017Reusable Dilator

Trademark Results [VersaStep]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VERSASTEP
VERSASTEP
88801320 not registered Live/Pending
Sundance Spas, Inc.
2020-02-18
VERSASTEP
VERSASTEP
88761382 not registered Live/Pending
IncStores LLC
2020-01-16
VERSASTEP
VERSASTEP
88751612 not registered Live/Pending
Glenn Safadago
2020-01-08
VERSASTEP
VERSASTEP
85374377 not registered Dead/Abandoned
Sundance Spas, Inc.
2011-07-18
VERSASTEP
VERSASTEP
78879641 3217683 Dead/Cancelled
POWER SYSTEMS (PS), LLC
2006-05-09
VERSASTEP
VERSASTEP
76322570 2804043 Live/Registered
COVIDIEN LP
2001-10-09

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