VersaStep VS101005
GUDID 10884521082830
Dilator and Cannula with Radially Expandable Sleeve
Covidien LP
Laparoscopic access cannula dilator| Primary Device ID | 10884521082830 |
| NIH Device Record Key | 19159a52-3c71-4847-b1ba-e8a762216252 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VersaStep |
| Version Model Number | VS101005 |
| Catalog Number | VS101005 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521082830 [Package] Contains: 20884521082837 Package: CASE [3 Units] In Commercial Distribution |
| GS1 | 20884521082837 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K012539
FDA Product Code
| GCJ | Laparoscope, general & plastic surgery |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-22 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [VersaStep]
| 10884521093614 | Insufflation Needle |
| 10884521093607 | Insufflation Needle |
| 10884521084193 | Radially Expandable Sleeve |
| 10884521084162 | Short Radially Expandable Sleeve |
| 10884521084155 | Long Radially Expandable Sleeve |
| 10884521084148 | Radially Expandable Sleeve |
| 10884521084131 | Short Radially Expandable Sleeve |
| 10884521084117 | Radially Expandable Sleeve |
| 10884521082861 | Dilator and Cannula with Radially Expandable Sleeve |
| 10884521082830 | Dilator and Cannula with Radially Expandable Sleeve |
| 20884521082806 | Dilator and Cannula with Radially Expandable Sleeve |
| 10884521081062 | Sterilization Tray |
| 10884521081055 | Reposable Sterilization Tray |
| 10884521081031 | Reposable Insufflation Needle |
| 10884521081000 | Reusable Dilator |
| 10884521080980 | Reusable Dilator |
| 10884521080959 | Reposable Dilator |
| 10884521080935 | Reposable Dilator |
| 10884521078581 | Reusable Cannula |
| 10884521078574 | Reusable Cannula |
| 10884521078550 | Reusable Cannula |
| 20884521084206 | Radially Expandable Sleeve |
| 10884521081048 | Reposable Insufflation Needle |
| 10884521078567 | Reusable Cannula |
| 10884521080966 | Reusable Dilator |
| 10884521080928 | Reposable Dilator |
| 10884521078598 | Reusable Cannula |
| 10884521081024 | Reusable Dilator |
| 10884521081017 | Reusable Dilator |
Trademark Results [VersaStep]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSASTEP 88801320 not registered Live/Pending |
Sundance Spas, Inc. 2020-02-18 |
 VERSASTEP 88761382 not registered Live/Pending |
IncStores LLC 2020-01-16 |
 VERSASTEP 88751612 not registered Live/Pending |
Glenn Safadago 2020-01-08 |
 VERSASTEP 85374377 not registered Dead/Abandoned |
Sundance Spas, Inc. 2011-07-18 |
 VERSASTEP 78879641 3217683 Dead/Cancelled |
POWER SYSTEMS (PS), LLC 2006-05-09 |
 VERSASTEP 76322570 2804043 Live/Registered |
COVIDIEN LP 2001-10-09 |
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