VersaOne FCSPASS
GUDID 20884521678702
Fascial Closure System Reusable Suture Passer
Covidien LP
Suturing unit, reusable| Primary Device ID | 20884521678702 |
| NIH Device Record Key | 79b5f8cd-18b3-4e26-ba2b-92df67882648 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VersaOne |
| Version Model Number | FCSPASS |
| Catalog Number | FCSPASS |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521678705 [Primary] |
| GS1 | 20884521678702 [Package] Contains: 10884521678705 Package: CASE [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163654
FDA Product Code
| GCJ | Laparoscope, general & plastic surgery |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
[20884521678702]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2017-09-14 |
On-Brand Devices [VersaOne]
| 40884521215437 | Universal Fixation Cannula |
| 40884521215420 | Universal Fixation Cannula |
| 40884521215413 | Universal Fixation Cannula |
| 30884521621057 | Blunt Trocar with Threaded Anchor |
| 20884521717661 | Universal Cannula Positioning Trocar System Standard |
| 30884521678709 | Fascial Closure System Reusable Suture Passer |
| 20884521717739 | Bladeless Positioning Trocar System Long |
| 20884521717722 | Bladeless Positioning Trocar System Standard |
| 20884521717708 | Bladeless Positioning Trocar System Standard |
| 20884521717678 | Universal Cannula Positioning Trocar System Long |
| 20884521515700 | Blunt Trocar with Threaded Anchor |
| 20884521548104 | Bladeless Trocar with Fixation Cannula |
| 20884521657714 | Bladeless Optical Trocar with Fixation Cannula |
| 20884521657684 | Bladeless Optical Trocar with Fixation Cannula |
| 20884521657653 | Bladeless Optical Trocar with Fixation Cannula |
| 20884521657646 | Bladeless Optical Trocar with Fixation Cannula |
| 20884521657639 | Bladeless Optical Trocar with Fixation Cannula |
| 20884521657622 | Bladeless Optical Trocar with Fixation Cannula |
| 20884521545141 | Universal Smooth Cannula |
| 20884521678702 | Fascial Closure System Reusable Suture Passer |
| 20884521185972 | Optical Trocar with Fixation Cannula |
| 20884521678726 | Fascial Closure System Bladed Trocar with Fixation Cannula Standard |
| 20884521794426 | Standard Optical Obturator |
| 20884521794433 | Long Optical Obturator |
| 20884521785851 | Long Optical Obturator |
| 20884521785844 | Standard Optical Obturator |
| 20884521785837 | Long Bladeless Obturator |
| 20884521785820 | Standard Bladeless Obturator |
| 20884521785813 | For use with Reusable Positioning Trocar System |
| 10884521784079 | Reusable Positioning Cannula |
| 10884521784062 | Reusable Positioning Cannula |
| 10884521784055 | Reusable Positioning Cannula |
| 10884521784048 | Reusable Positioning Cannula |
| 10884521784031 | Reusable Positioning Cannula |
| 10884521784024 | Reusable Positioning Cannula |
| 20884521678719 | Fascial Closure System Optical Trocar with Fixation Cannula, Standard |
| 20884521657707 | Bladeless Optical Trocar with Fixation Cannula |
| 20884521657691 | Bladeless Optical Trocar with Smooth Cannula |
| 20884521657677 | Bladeless Optical Trocar with Fixation Cannula |
| 20884521657660 | Bladeless Optical Trocar with Fixation Cannula |
| 20884521593463 | Bladed Trocar with Fixation Cannula |
| 20884521548098 | Bladeless Trocar with Fixation Cannula |
| 20884521546919 | Bladeless Trocar with Fixation Cannula |
| 20884521546902 | Bladeless Trocar with Fixation Cannula |
| 20884521546896 | Bladeless Trocar with Smooth Cannula |
| 20884521546889 | Bladeless Trocar with Fixation Cannula |
| 20884521546872 | Bladeless Trocar with Fixation Cannula |
| 20884521546865 | Bladeless Trocar with Fixation Cannula |
| 20884521546858 | Bladeless Trocar with Fixation Cannula |
| 20884521546841 | Bladeless Trocar with Fixation Cannula |
Trademark Results [VersaOne]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSAONE 98583233 not registered Live/Pending |
Versa Networks, Inc. 2024-06-04 |
 VERSAONE 86373439 4783397 Live/Registered |
Covidien LP 2014-08-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.