Signia SIGSDL45CTVT
GUDID 20884521741840
Small Diameter Curved Tip Intelligent Reload Vascular/Thin; For use with 8 mm Cannula or larger
Covidien LP
Surgical staple loading unit, non-cutting| Primary Device ID | 20884521741840 |
| NIH Device Record Key | 0348e0e2-10b9-4567-a2ae-4f77645b83e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Signia |
| Version Model Number | SIGSDL45CTVT |
| Catalog Number | SIGSDL45CTVT |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
Device Dimensions
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 8 Millimeter |
| Length | 45 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 94 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521741843 [Primary] |
| GS1 | 20884521741840 [Package] Contains: 10884521741843 Package: PACK_OR_INNER_PACK [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191070
FDA Product Code
| GDW | Staple, implantable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-04 |
| Device Publish Date | 2019-09-26 |
On-Brand Devices [Signia]
| 10884521543829 | Linear Adapter Short |
| 10884521543805 | Linear Adapter |
| 10884521543898 | Sterilization Tray |
| 10884521703704 | Circular Adapter Reusable Trocar Tip Protector |
| 10884521703698 | Black Extra Thick Circular Adapter XL Length |
| 10884521703681 | Circular Adapter Standard Length |
| 20884521543796 | Power Shell |
| 20884521741888 | Small Diameter Curved Tip Intelligent Reload Vascular/Thin; For use with 8 mm Cannula or larger |
| 20884521741871 | Gray Small Diameter Curved Tip Intelligent Reload Vascular; For use with 8 mm Cannula or larger |
| 20884521741840 | Small Diameter Curved Tip Intelligent Reload Vascular/Thin; For use with 8 mm Cannula or larger |
| 10884521543850 | Four-Bay Smart Charger |
| 10884521543867 | Single-Bay Charger |
| 10884521543782 | Power Handle |
| 10884521543812 | Linear Adapter XL |
| 10884521797437 | Power Handle, Refurbished |
| 20884521543505 | Loading Unit |
| 20884521543499 | Loading Unit |
| 10884521543874 | Reusable Insertion Guide |
| 10884521543881 | Manual Retraction Tool |
| 10884521845497 | SIGNIA CIRCULAR ADAPTER XL LENGTH FT |
| 10884521845480 | SIGNIA CIRCULAR ADAPTER STND LENGTH FT |
Trademark Results [Signia]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIGNIA 90981018 not registered Live/Pending |
Hilton International Holding LLC 2021-03-18 |
 SIGNIA 90701068 not registered Live/Pending |
Closet World, Inc. 2021-05-10 |
 SIGNIA 90586775 not registered Live/Pending |
Hilton International Holding LLC 2021-03-18 |
 SIGNIA 90577665 not registered Live/Pending |
Hilton International Holding LLC 2021-03-13 |
 SIGNIA 90380652 not registered Live/Pending |
Jeffery Fell 2020-12-14 |
 SIGNIA 88704276 not registered Live/Pending |
Signia Artwork, LLC 2019-11-23 |
 SIGNIA 88383023 not registered Live/Pending |
SIG Technology AG 2019-04-12 |
 SIGNIA 87743868 not registered Live/Pending |
Hilton International Holding LLC 2018-01-04 |
 SIGNIA 87588391 not registered Dead/Abandoned |
EE CAPITAL LIMITED 2017-08-29 |
 SIGNIA 86450957 5119954 Live/Registered |
Covidien LP 2014-11-11 |
 SIGNIA 86009779 not registered Dead/Abandoned |
EE CAPITAL LIMITED 2013-07-14 |
 SIGNIA 85859446 not registered Dead/Abandoned |
Choi, David 2013-02-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.