SGIA
GUDID 20884523007296
Knifeless Stapler with DST Series Technology
Covidien LP
Open-surgery manual linear stapler, single-use| Primary Device ID | 20884523007296 |
| NIH Device Record Key | 41129993-1fbd-4d43-ad1e-c12fc10cb264 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SGIA |
| Version Model Number | SGIA6038S |
| 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 |
Device Dimensions
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
| Length | 60 Millimeter |
| Height | 3.8 Millimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884523007299 [Primary] |
| GS1 | 20884523007296 [Package] Contains: 10884523007299 Package: CASE [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111825
FDA Product Code
| GDW | STAPLE, IMPLANTABLE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-03-15 |
| Device Publish Date | 2015-09-02 |
Devices Manufactured by Covidien LP
| 20884521703732 - Tri-Staple 2.0 | 2024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters |
| 20884521703756 - Tri-Staple 2.0 | 2024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters |
| 20884521703770 - Tri-Staple 2.0 | 2024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters |
| 20884521822891 - DAR | 2024-12-09 Closed Suction System, Replaceable Catheter Endotracheal Length |
| 10884521845480 - Signia | 2024-12-09 SIGNIA CIRCULAR ADAPTER STND LENGTH FT |
| 10884521845497 - Signia | 2024-12-09 SIGNIA CIRCULAR ADAPTER XL LENGTH FT |
| 20884521581859 - Barrx | 2024-11-18 RFA Cleaning Cap Small |
| 20884521581866 - Barrx | 2024-11-18 RFA Cleaning Cap Medium |
Trademark Results [SGIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SGIA 85692135 4295774 Live/Registered |
Specialty Graphic Imaging Association 2012-08-01 |
 SGIA 74574918 1994074 Live/Registered |
SPECIALTY GRAPHIC IMAGING ASSOCIATION 1994-09-19 |
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